chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration unknown) at a pharmacy on or about 29-JUL-2012 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-NOV-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed LIPODERM and famciclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Started with a mild headache which hasn't gone away despite otc pain meds.  Then progressed to fatigue,  swollen legs and ankles, shortness of breath, mild chest pain and several instances of abnormal heart rhythm (flutter in chest). Still  having these issues
Received PNEUMOVAX 1-3-17. Wife also received and had no problem. Said husbands was given in the back of the arm and had pain, swelling, redness in arm and pain in shoulder. Advised ice and supervisor will contact pt.
Flu; Sweat; Chills; Ear ache; Sore throat; Loss of appetite; Dry heaves; Cramps in my back; Stomach pain; Neck pain; Feel tried; Face feel itchy; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced flu, sweat, chills, ear ache, sore throat, loss of appetite, dry heaves, cramps in my back, stomach pain, neck pain, feel tried, face feel itchy on an unspecified date. Consumer Stated, she got this 2nd Pfizer vaccine Wednesday 05May2021 and she just want to ask, she had very bad side effect from the second vaccine, she had, she feel like she had the flu, the sweat and the chills, sore throat, loss of appetite, dry heaves, stomach pains , cramps in her back and on neck pain , ear ache, feel tried, her face feel itchy. she just wanted to know was that the normal side effects from the vaccine. When probed for Reporting AE, consumer Stated, Yeah, she would and she wanted to ask, was this how can do long feel you have this flu like symptoms, how long does it last after the second vaccine. Consumer was told to contact agency for the questions. The clinical outcome of all the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Arthralgia, Myalgia, Chest discomfort, Cardiac murmur and Sinus bradycardia. Previously administered products included for Immunization: Influenza (series 1) on 03-Oct-2018, Influenza (series 2) on 28-Sep-2020 and Influenza (series 3) on 15-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza, Influenza and Influenza. Concurrent medical conditions included Pedal edema, Weight gain, Hypertension, Benign neoplasm of carotid body (right), Synovitis wrist (tenosynovitis, left wrist), Reactive airways disease, Bronchitis acute, Paroxysmal atrial fibrillation, Cerumen impaction, Hyperlipidemia, Postmenopausal symptoms, Hypothyroidism, Osteopenia and Hypertension (FH). Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR), VITAMIN D3, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B12 NOS, LEVOTHYROXINE, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR), LOSARTAN POTASSIUM, UBIDECARENONE (COQ 10) and MAGNESIUM for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) abnormal, right breast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 11 Nov 2021.  Patient lab data includes screen (ovarian Cancer, lung Cancer, skin cancer, breast cancer, osteoporosis, cervical cancer, colon cancer), preoperative examination, physical examination. The patient had anticoagulant therapy.  Patient other medication included SARS COV 2 SEMI QUANTITATIVE and anti hyperlipidemic use(Long term), centrum silver oral tablet (multiple vitamins- minerals) one by mouth once a day.  Patient services due included Flu vax, Pneumovax, TD Booster.  No treatment medications were reported.
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
Information has been received from a pharmacy technician concerning a female who on 06-JUL-2007 was vaccinated by injection with Gardasil, ("lot unavailable"). On 06-JUL-2007 the patient experienced a metallic taste in mouth, nausea, vomiting and taste remained for a few hours after receiving Gardasil. The patient sought unspecified medical attention. At the time of the report the patient had recovered. No additional information was provided. Additional information has been requested.
diarrhea started 14OCT93 the day p/the shot & cont for 12 days-gradually improving;
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that GARDASIL dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007203, 1405USA007978, 1405USA007982, 1405USA008052 via same reporter link. Additional information has been requested.
J&J vaccine was administered to patient. Consent form states that patient will be receiving J&J vaccine today. Pt is confused per medical baseline. Notified facility nurse, RN that I will be given J&J to patient and was okay with giving. After vaccine was given a second facility nurse, RN confirmed that pt was supposed to received second dose of Pfizer vaccine today. Pt was closely monitored in area for 30 minutes, facility Dr was notified. No acute distress noted, vital sign stable,  no reactions noted, no active bleeding noted during 30 minutes of observation. Pt was taken back to her room and 15 minutes after observation at around 09:35AM, facility staff notified pt was desatting, was placed on oxygen and ambulance was called and taken to emergency room.
Starting in 01/2022 I have had high blood pressure. I never had it before getting the vaccine. My doctor prescribed me valsartan 80mg. It has been keeping me under control so far. Also, more recently I am having severe sciatic nerve pain again in my entire right leg. It has lasted about 7 weeks. I am in physical therapy but the pain is still pretty bad. This pain started in the summer of 2021.
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with hepatitis a vaccine, inactivated was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with hepatitis a vaccine, inactivated was unknown. This is one of the many reports from the same source. Additional information has been requested.
several bumps- 2wk arm hurt; 29JAN99 woke up paralyzed rt hand, arm, wrist, fingers, initially dx radial nerve palsy; 10APR99 lt hand now exp is same wrist won't flex, atrophy-bilat arms; sx cont to worsen;
pain, redness and swelling at injection site, fever up to 101.5, chills, body aches, and headache
A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today; 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 PRODUCT DOSE OMISSION ISSUE (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Developed rash, purperet lesions were noted on chest abdomen back-arms & legs - also several small bruises noted on different areas of body;
A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment of accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
6cm of redness and induration; worst at 24 hours, improved at 48 hours. Treated as an allergic reaction with Benadryl on right arm (side of DTaP and IPV).
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA, 50 U/1ml injection, lot # J014589, expiration date 15-JAN-2016 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for eight times. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) were as following: 34 F for 136 hours, 32 F for 120 hours, 31 F for 288 hours, 30 F for 1400 hours, 29 F for 24 hours, 26 F for 472 hours, 27 F for 208 hours and 28 F for 1128 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
TOOK ONLY ONE DOSE OF VIVOTIF; This spontaneous case (PVX2019-2358) was received from a pharmacist on 13-Sep-2019. It described a male consumer, who "took only one dose of Vivotif" (PT: Incomplete course of vaccination), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 04-Sep-2019, then stopped taking the further doses, because he was traveling temporarily and could not keep it in the refrigerator.   Action taken with Vivotif with respect to the event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.
Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 7/29/2022 Discharge Date: 8/3/2022  PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 78 year old male with a PMH of hypertension, CAD, hyperlipidemia, type II diabetes mellitus, CKD stage III, BPH, HF, dementia and Parkinson's disease.    Patient started experiencing increased weakness and falls. Patient also had been experiencing fatigue, weakness, fevers/chills, nausea, body aches, dry cough, and decreased appetite since 7/27/2022.  Due to increased weakness, patient started to fall at home. Patient had fallen twice in 2 days prior to presentation to the ER.    While in ER, lab work was unremarkable. Patient was positive for COVID-19. An EKG shows normal sinus rhythm with left bundle branch block.  A CT head showed no acute intracranial abnormality and a CT cervical spine was negative for acute fracture or malalignment.  A chest x-ray shows no acute cardiopulmonary findings however there are multiple hyperdense foreign bodies in the right lower lobe that is suspicious for aspiration of a high density material. The patient and daughter could not remember a recent significant aspiration event. Given the patient's recent falls and generalized weakness he was admitted to the hospitalist service for ongoing management of generalized weakness and COVID-19.     During his admission, patient did not have respiratory symptoms and remained on room air during course of hospitalization. Due to lack of respiratory symptoms, patient was not started on dexamethasone and remdesivir. While admitted, PT, OT, and SLP was consulted. PT and OT recommended discharge to skilled nursing facility for rehab. Speech therapy recommended thin liquids, soft and bite-sized (dysphagia advanced), no straws. Pills to be given whole in puree. The patient's daughter stated that if the patient needs to be placed in a facility for rehabilitation she would prefer at a certain facility. Unfortunately, patient was unable to be placed. Family elected to have home PT/OT/speech therapy and a home nursing aide. At this time, patient is medically stable for discharge. Plan to continue home PT/OT/Speech therapy and home nursing with aid. Plan of care discussed with patient and family. They are agreeable to plan at this time. Questions answered to their satisfaction.
Pt recv vax on 10/14/98; on same day pt exp round, swollen, erythematous, warm rx at vax site; pruritic & wheezing
Muscle stiffness in Right arm (opposite of injection arm), neck stiffness (can not look up), could not sleep. This has been happening and slowly getting worse over the past 18 hours.
fever to 102 x 3 days; starting 25MAR94; spots over entire body;
Breakthrough case admission after 3 vaccines Pfizer 3/31/21 Lot# ER8730;  Pfizer 4/21/21 Lot# EW0162;  Pfizer 12/10/21 Lot# FH8027
numbness/tingling lt foot & tingling rt hand started 4 days p/vax;was intermittent;stopped p/3 days & began again & got worse in rt hand extending to elbow 2 days later stopped 2 days later;
This spontaneous report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant therapies were not reported. From 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M038572, expiration date 11-MAR-2018 (dosage and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion of -1°C or colder for a time frame of 15 minutes because of data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1709USA008713.
I felt burning sensations at the top of my head. It kind of stayed there and intensified from burning pain to nerve pain by the 17th of April. Then I went to seek a doctor on May 3rd. No tests were performed on that date. Acyclovir was prescribed.
Racing heart; Dizziness; Headache; Hives; Mild throat swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot m100003243928, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: shellfish, soy, nuts, sunflower seeds, sesame, mustard, bananas, apricots, peaches; and COVID-19 on an unknown date. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) and over the counter allergy medication. Lab test on an unknown date included COVID-19 was positive. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Mar2021 at 10:30, the patient experienced racing heart, dizziness, headache, hives, mild throat swelling. Treatment for the events racing heart, dizziness, headache, hives, mild throat swelling included diphenhydramine (BENADRYL), epinephrine (EPIPEN), and inhaler. The outcome of the events racing heart, dizziness, headache, hives, mild throat swelling was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Shortly after receiving the vaccine. Patient developed a full body rash - flat and red. She had also just finished an Rx of AUGMENTIN for strep throat.
swelling a little bit at the injection site was reported as worsened/ a little red at the injection site was reported as worsened/ itching at the injection site was reported as worsened; swelling a little bit at the injection site; a little red at the injection site; itching at the injection site; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 (Lot number: FH8028) at the age of 67 years as dose 3 (booster) , single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot,no- EN6201), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, EN6206), administration date: 06Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster dose"; VACCINATION SITE SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "swelling a little bit at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Dec2021, outcome "not recovered", described as "a little red at the injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "itching at the injection site"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "swelling a little bit at the injection site was reported as worsened/ a little red at the injection site was reported as worsened/ itching at the injection site was reported as worsened". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  Additional information: No other products and no patient history. There was no investigation assessment.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant also a office manager regarding a 25 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-NOV-2016 or 17-NOV-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M009378, expiration date: 23-APR-2018) (dose, frequency and anatomical location not reported) intramuscular. The administered dose experienced a temperature excursion of 26 F for 18 hours, 52 F for 3 hours on 16-NOV-2016 and 22F for undetermined amount of time on 17-NOV-2016. Previous temperature excursion includes 49 F for 70 hours on 14-NOV-2016. The call was not because of data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.