chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in an unspecified number of patients who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event, wrong injection technique and off label use. On an unknown date, the outcome of the adverse event, wrong injection technique and off label use were unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that, they had a few patients that did not tolerate flu vaccines well. For the flu vaccine they gave these patients half doses a week a part, which led to wrong injection technique and off label use. The HCP did not provide which flu vaccines the patients had been given.
Felt hot and sweaty about 30 min after receiving vaccine stated "I feel- not like I can't swallow but my throat feels tight- like when I take MORPHINE at the hospital"  Patient skin was clammy face flushed- BP 133/70 P 89-89 R 16-18, PO2 98% T.  98.5 oral-  Seen by in-house MD- BENADRYL 125 mg by mouth ordered & given.
arm pain; Fever; headache; strong fatigue; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a subject with unknown age and gender, with no reported medical history, who experienced the expected non-serious event of arm pain. The rechallenge was not applicable, as there is limited information available. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
The immunizations were given just 3 weeks after first series; making them 1 week too soon. All immunizations cannot be counted and will be repeated in 1 month.
PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain.  CXR consistent w/multilobar pneumonia & COPD.
Crepitus and effusion in right knee; crepitus in left knee and neck. Some pain in finger joints, fatigue, some pain in hips and morning stiffness. 2nd Lymerix, lot #LY120B9 was given on 2/24/99 and 3rd Lymerix, lot #LY130A9 was given on 2/16/00. Per doc 214744, pain and stiffness in knees, neck and hips.
PATIENT DEVELOPED RED KNOT IN LEFT DELTOID WITHIN 7 DAYS OF VACCINATION.
Administration error. Vaccines delivered to Family Medicine 12/2022. Vaccines with expiration date on vial says 09/2022.  Expiration date in Immunization Information System states expiration of 08/2023. Patient given vaccine when vaccines were supposed to be thrown out at 10 week from arrival date. Vaccine is supposed to be viable even though given after Public Health expiration date.  NO adverse event occurred.
Arthralgias of shoulders, hips, ankles; whole body myalgias; sore injection site beginning about 10 hours after administration and progressively worsening to peak severity about 24 hours after administration. Gradually resolving thereafter. Fully resolved about 30 hours after administration with no treatment or intervention.
Initial report received from office staff of health care on 18 May 2012. Number: 12-0292. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL on an unspecified date (lot number, route and site of administration was not reported). It was reported that on an unspecified date the patient experienced a dollar sized red mark at the injection site with a white ring around the mark and had temperature (100) for 2 days the patient also reported that she felt horrible for 3 days. The outcome of the adverse reaction was not reported. The complimentary investigations and corrective treatments were not reported. List of documents held by sender: none.
pt. had a syncopal episode post receiving a partial vaccination, Pt. was helped to the floor by staff without injury and immediately recovered  Pt. was able to stand and seat himself on the litter where he was then taken to Observation Pt. had no other symptoms or reactions and requested and was given a full vaccine in the opposite arm the left arm without incident  Pt. was discharged after additional 15 minute observation
Patient received 3rd Moderna booster (0.5ml) on 11/10/21. Patient self attested that she was immunocompromised. She called back on 11/13/21 saying she still has symptoms: body aches, chills, fever and has a hard time lifting her arm. She also reported some tenderness in her armpit area. She said that her shot was given off center on the arm but not high on shoulder. We recommended the patient to come visit pharmacy to assess. She asked if she can get a MD note for her employer, but told her that we don't provide notes to take days off work. We suggested that she go visit a doctor and that we will follow up with her.
12/04/21 presents to ED for "sob and fatigue". PMHx of "renal transplant, CAD, AFib"
has been having episodes of tachycardia (130s), anxiety, cold, clammy, flushed, unable to think/concentrate, brain fog, and extreme fatigue/exhaustion; with time these episodes pass and she is left with severe exhaustion; occurred so far on 4/2, 4/6, and 4/14. She is also undergoing allergy shots- she did not receive any allergy shot for 1 week prior to the initial vaccine and through 1 week after her last allergy shot- I do not prescribe nor administer those, so I do not know the makeup
hurts to go up the steps and can be difficult getting out of bed; pain in the right hip extends from the groin; developed a headache; feverish; Achy; slept 18 hours a day for two to two and half days; She's still a little more fatigued than usual and taking more naps.; left-sided hip inflammation and pain; left-sided hip inflammation and pain; right hip was so painful it felt like it could be a bone cancer; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 27Apr2021 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included degenerative back issue on her right side and COVID-19 on an unspecified date (reported as "this winter") for five and half weeks, she was not sure if it was so severe because of her blood type B positive. The patient's concomitant medications were not reported. Two hours after the vaccine, on 27Apr2021, the patient developed a headache, was feverish, achy, and slept 18 hours a day for two to two and half days. She still had a little more fatigue than usual and was taking more naps since 27Apr2021. She also developed hips pain on both sides and never had prior hip problems. She did have a degenerative back issue but it was on the right side and her physical therapist said that the hip pain was not due to her back issue. The left-sided hip inflammation and pain resided, but the right hip was so painful it felt like it could be a bone cancer and she felt like she could cry. It hurt to go up the steps and can be difficult getting out of bed. The pain in the right hip extends from the groin around and to the far side of the hip. The patient wanted to know if she can delay receiving the second dose of vaccine. The outcome of the event "slept 18 hours a day" was recovered in Apr2021 (for two to two and half days), left hip inflammation and pain was recovered on an unspecified date in 2021, right hip pain and fatigue was not recovered, and outcome of the other events was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Between 09-JAN-2018 and 16-FEB-2018, the patients were vaccinated with improperly stored doses of PROQUAD lot # N024563 with expiration date on 06-MAR-2019 (dose and route of administration were not reported) or improperly stored doses of VARIVAX lot # N017395 with expiration date on 07-JUN-2019 and lot # N008829 with expiration date on 16-MAR-2019. Properly stored doses of sterile diluent (MERCK) were used to reconstitute the doses of the vaccines. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 9 hours and 57 minutes. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 15 to 46 degrees Fahrenheit for 33 hours reported. This is one of several reports received from the same reporter.
pt had chickenpox 25DEC & ear infect @ some time on ATB;child had wheeze since born;pt recv vax & was fussy & felt warm;no temp measured;20JAN devel sl cold-clear mucous;child found not breathing 9:15;poss SIDS autopsy pending;
Administered with the vaccine from a vial which was punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021 at 3:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 09-Nov-2021 at 3:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours). On 09-Nov-2021 at 3:53 PM, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  Vial was initially punctured on 05 Nov 2021 at 10:00AM.
No adverse effects noted. Pt. given PREVNAR instead of PNEUMOVAX accidently given by fill-in nurse helping that morning
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated subcutaneously with a dose of VARIVAX (0.5 ml, lot# and expiration date were not reported) after that vaccine was exposed to a temperature excursion of 12 degrees F for 1 hour. No adverse effect was reported. No PQC (product quality complaint) was reported. Additional information has been requested.
FEVER 103.9, RESOLVED. INTERMITTANT TACHYCARDIA 130 BPM, ONGOING.
Client received Tdap and Menactra vaccine, told mother he felt funny, became diaphoretic, pale, decreased responsiveness, closed eyes. Client went to biosafety station for assessment became more responsive. Client improved and left clinic at 1815 with no symptoms and stable.
Admitted for malignant HTN and stroke, found to be COVID +. Tox screen + cocaine. Fully vaccinated. Placed on steroids, did not require O2. Both documentation of "incidental finding" and "COVID pneumonia" are found. Patient left AMA
only gave the DTaP/IPV portion of the vaccine and not the ACTHIB portion with no reported adverse event; Initial information regarding this unsolicited valid non-serious case via Global Medical Information (GMI) (Reference number- 00504955) was received from a pharmacist and transmitted to Sanofi on 04-Mar-2021.  This case involves a patient of unknown age who only gave the dtap/ipv portion of the vaccine and not the acthib portion (incorrect dose administered) for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ502AA and expiration date: unknown) for prophylactic vaccination.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to the incomplete dose administered (latency: unknown).  At the time of reporting, the patient had no adverse event.  Disclaimer: 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.
Itchy pink, warm to touch start 11/1/22 small - today 11/4/22 itch pink Large about 60mm pt was told to take Zyrtec in AM & Let us know on Monday how she is doing, (Back)
This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to unspecified patients of unknown ages and genders who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported) by oral route. No symptoms were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Hospital Course:       Patient is a 82-year-old female with a previous history of severe dementia who was admitted via EMS, patient without ability to give significant history, per family she has stopped walking and had stopped eating or drinking and that they were concerned he could no longer take care of her at home.  In patient with history of underlying dementia, she was admitted to the hospitalist service.  His CT was negative for acute CVA, during this admission patient was diagnosed with metabolic encephalopathy superimposed on severe underlying dementia.  The patient was severe debility info to thrive, palliative Care was involved but family declined from hospice requested PEG tube.  Peg tube was placed, patient also tested positive for COVID, she tested positive on/7, respiratory symptoms resolve 7/14.  Patient was still positive may discharge.  On the day discharge, patient still with waxing waning encephalopathy, debility failure to thrive.  Patient is currently a full code, concerned that patient is having worsening clinical decompensation secondary to her severe dementia and is more appropriate for end of life care, however family has  Refused.  Patient had PEG tube placed 7/10, currently on tube feeds, discharged to skilled nursing facility.     Altered mental statu -Acute metabolic encephalopathy - progressive weakness/ debility + poor po intake x 3 days, after exposure to Covid; covid positive on admission. CT head no stroke/bleed.  UA unremarkable.  Ammonia wnl. prob 2 to acute Covid infection on top of underlying dementia. Improved some but far from baseline.   Debility, failure to thrive - palliative involved - family declined referral to hospice for end of life care, requested PEG. Perc GJ tube placed on 7/10 - TF via J tube, meds via G tube.    COVID-19 infection - +cough but not SOB. CXR u/r. Mucinex. No hypoxia, no indication for steroids or remdesivir at this time. Sxs noted 7/5. Tested positive 7/7. Resp sxs resolved 7/14. Repeat covid pcr 7/17 POSITIVE (prob Day 11-12   Dementia - chronic, prob Alzheimer's. Also HOH. Worsening even before acute illness. PT/OT if tolerated. Resume memantine/ donepezil (Home med   Ess HTN - unable to take meds. Home meds per G tube. BP now w/in acceptable limits.    Patient is a FULL CODE     Significant Diagnostic Studies:    Ct Abdomen and Pelvis: Nonobstructing renal stones.   Left renal cyst.   The stomach is not well distended.   Other findings as detailed above.         Procedure(s):  Placement of 18 Fr x 45 cm percutaneous gastrojejunostomy tube (Perc GJ) under fluoroscopic guidance. 7/9/2022
This spontaneous case reported by a consumer, describes the occurrence of cardiac disorder (I'm going in for a pace maker surgery tomorrow) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cardiac disorder (I'm going in for a pace maker surgery tomorrow). At the time of the report, cardiac disorder (I'm going in for a pace maker surgery tomorrow) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication, lab data or treatment information reported.
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d  After 2 days of vaccine she started feeling right leg heaviness  (whole leg) , she was dragging when she walks  But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness,  no extremities weakness  She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away.  When she went  for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology.  MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
No adverse effect reported; PROQUAD that underwent a temperature excursion were administered to an unspecified number of patients; This spontaneous report as received from a medical assistant refers to a 4-year-old male patient.  Information about medical histories, concurrent conditions and concomitant therapies was unknown.  On 07-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S024054 which is invalid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), expiration date: 01-DEC-2020; route and strength were unknown) that underwent a temperature excursion were administered to the patient for prophylaxis.  Temperature excursion was reported as range -0.52 Celsius degrees(C) for time frame 10 hours and 34 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013604: US-009507513-2005USA009319:
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) ROTATEQ lot # N000172 (expiry date: 10-JUN-2018) orally (dosage not reported) for prophylaxis. A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011456: US-009507513-1804USA011627: US-009507513-1804USA011628.
COVID-19; vaccination failure; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 029L20A and 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (vaccination failure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19) to be related. No further causality assessment was provided for VACCINATION FAILURE (vaccination failure).    Race of the patient was reported.  Patient's age was reported as approximately 59 or 61.  Concomitant medications details were not reported.  The reporter was nurse who was reporting for herself. It was reported that the patient had non the damage of symptoms (further clarification unknown) but said was grateful that patient does not had any lung or cardiac involvement, so patient just said annoying cough occasionally, loss of appetite and said that was out of work for 2 weeks. She had COVID in mid of October 2021. Patient was fine at the time of reporting.   No treatment information was reported.  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.
Information has been received from a physician concerning a 30 year old male with hypertension and a history of cardiac transplant whose child was vaccinated in March 2005 with a dose of Varivax. On approximately 14-APR-2005, the father developed herpes zoster. He had a non-productive cough, myalgia, anorexia, and muscle spasms. He went to the ER where he was found to be febrile and had vesicular lesions on his head, face, upper torso, on all extremities and on lesion in his mouth. He was treated with acyclovir and admitted to the hospital. Subsequently, the pt recovered. A product quality complaint was not involved. The pt's experiences were determined to be other important medical events (OMIC) by the reporter. Additional information has been requested.
Sx: puffy eyes, weight gain. Dx: hyponatremia. Tx: furosemide, IV fluids. Note: influenza vaccine administered (outpatient) prior to hospital admission.