chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: DIVERTICULITIS OF SIGMOID W PERFORATION   Key findings related to primary problem: T 99.3, WBC 12.4, IV Ceftriaxone & Metronidazole, maintenance IVF.  NPO x meds, denies N/V/abd pain at this time.  Abdomen soft, tender to touch, guarded, bowel sounds hypoactive.  ERAS interventions, CHG wipe.   Other key findings: Patient seen at least every hour by nursing staff (or assigned designees) throughout the shift.   Covid detected, notified Dr., implemented Enhanced Respiratory & Contact Precautions.           Note Details  Author (R.N.) File Time 10/29/2023  7:54 PM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Admit Date 10/29/2023 ED to Hosp-Admission (Discharged) on 10/29/2023     ED to Hosp-Admission (Discharged) on 10/29/2023       Detailed Report     Note shared with patient
Information has been received from a lawyer regarding a case in litigation concerning a male 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 ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-MAR-2015, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated at an urgent care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. 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.
Head to toe rash 4 hours after receiving vaccination. Also complained of sore throat and fever which in combination with rash lead patient to be evaluated in ED on 3/28
Sore arm at injection site, Headache, Fever of 100F-101F, Fatigue until end of next day.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had pain in his past medical history and concurrent conditions included: Chronic lymphocytic leukaemia (CLL) also had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Imbruvica (ibrutinib) for Chronic lymphocytic leukaemia (CLL), calcium carbonate, dexamethasone, Dramamine (dimenhydrinate), ibuprofen, loperamide, Prilosec (omeprazole), and Acetaminophen (paracetamol) for unknown indication. On AUG-2021, the patient did the Severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) antibody test which showed negative results, hence confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210856371 and 20210447536. This case is associated with RA: 90000192062.; Sender's Comments: V0.20210904096-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY, SPECIAL SITUATIONS
pfizer was given as second  shot to a moderna first shot.. Mixed dose error.  Prophysaxis manager informed pt that the 2 vaccines do not interact with each other and she is adequately vacccinated.  No further follow up needed by pt. Gave her number of vaccine help line if she has further questions.
1 and 1/2 inch of erythema at site.  No warmth, no induration, minimally tender.
devel hyporesponsive episode (difficult to arouse) w/in 1-2 hrs p/vax; mom also noted mottled coloring;
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Severe decrease in heart rate and CHF-Severe, Additional Details: The patient states that he has Graves Disease.  After receiving the COVID vaccine he states that his heart rate dropped dangerously low, he was hospitalized and had cardiac problems and developed heart failure.  He is now out of the hospital, but is still recovering and is requiring monitoring and echocardiograms to asses his heart function.
ITCHINESS AROUND ARM AND ABOVE WRIST ON SAME SIDE AS AFFECTED LEG; SKIN REACTION ON ARM; RASH ABOUT 4 INCHES AROUND ANKLE AND BELOW LEG ON ONE LEG; BRIGHT RED SKIN REACTION ABOUT 4 INCHES AROUND ANKLE AND BELOW LEG ON ONE LEG; This spontaneous report received from a pharmacist concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bright red skin reaction about 4 inches around ankle and below leg on one leg. On APR-2021, the subject experienced skin reaction on arm. On APR-2021, the subject experienced rash about 4 inches around ankle and below leg on one leg. On JUN-2021, the subject experienced itchiness around arm and above wrist on same side as affected leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash about 4 inches around ankle and below leg on one leg, bright red skin reaction about 4 inches around ankle and below leg on one leg, itchiness around arm and above wrist on same side as affected leg, and skin reaction on arm. This report was non-serious.
ruptured appendix; Cramps in his lower intestine; Shoulder started getting a little sore; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (ruptured appendix) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, ALLOPURINOL and TOPIRAMATE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ARTHRALGIA (Shoulder started getting a little sore). On 13-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Cramps in his lower intestine). On an unknown date, the patient experienced APPENDICITIS PERFORATED (ruptured appendix) (seriousness criterion hospitalization). At the time of the report, APPENDICITIS PERFORATED (ruptured appendix) had resolved and GASTROINTESTINAL PAIN (Cramps in his lower intestine) and ARTHRALGIA (Shoulder started getting a little sore) outcome was unknown.            The patient took Tums antacids which helped for a little while and he took milk on 14-Jan-2021. For ruptured appendix, patient  had surgery in the hospital.  Although a temporal association exists, based on the current available information,  the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The  event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated.  The causality of the event of arthralgia is assessed as possibly related.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: An event  ruptured appendix was added with treatment information.; Sender's Comments: Although a temporal association exists, based on the current available information,  the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The  event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated.  The causality of the event of arthralgia is assessed as possibly related.
INJURED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20220447899.
When in for a dental visit and my blood pressure was abnormally high so I purchased a blood pressure cuff and my diastolic reading was over 90 and I cannot pass my medical for work unless it is under 95.  Talked with my primary care doctor and she put me on BP meds then I also visited a heart specialist and he changed my meds and added cholesterol meds to the mix but I have been borderline high for a few years and controlling with diet.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 47 years old female patient who experienced shoulder pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Bursitis in left shoulder. The patient did not receive any concomitant medication. Notes- The patient has a MIRENA IUD in place so does not get regular periods. On 05-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AB, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious shoulder pain with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of an actual medication error due to Vaccine administered at inappropriate site as FLUZONE QUAD was given in the deltoid or was perhaps not entirely in deltoid, given too high on a patient's arm, unsure if it was injected in right place. Lab data was not provided. Final diagnosis was shoulder pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for shoulder pain. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Chronic pain, major limited mobility. Patient visited a doctor as a result. Patient was diagnosed w/Impingement Syndrome by orthopedic.
Patient developed dizziness, severe headache and flue like symptoms with body aches that persisted for 3 weeks, starting about 1 day after the injection. The dizziness has continued to persist: she cannot drive or walk down the street. She cautiously waks from room to room in the house, but stays near a wall. She says the dizziness is not quite as severe as it was initially. She is working with PT.  It has been 8 weeks and she is still handicapped by dizziness.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment information was provided by reporter.   This case was linked to MOD-2021-417618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up information received contains significant information: Updated patient's details and product details.
Five days after his vaccination experienced petechiae rash above his lip and underneath his nose. It gave the appearance of a mustache. It appeared with flush cheeks and lasted for about two days before resolving.
No additional AE information provided.; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical condition and concurrent condition were not reported.  On 21-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R020651with expiration date: 18-JUL-2020; dose, strength, frequency and route unknown) for prophylaxis. The sterile diluent (STERILE DILUENT) was properly stored. There was no additional event.   The vaccine was stored under 6 Fahrenheit (F) to 14F (13.6F) for 8 hours and 14 minutes. There was no previous temperature excursion. The digital data logger was involved.
This spontaneous report as received from a medical assistant refers to a 14-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 20-JAN-2016, the patient was vaccinated with an improperly stored, the third dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
High fever, up to 103.5 (rectal) followed by seizure lasting less than 2 minutes. Rash appeared 2 days after fever. Followed up with Dr. visit on the next day.
slept all day; This is a spontaneous report received from a contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "slept all day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began day after vaccines and still present at MD appt 5 days later with increased redness to bilateral cheeks. Mild reaction. Cheek flushing. No other symptoms noted.
Pfizer vaccine administered two days after the Beyond use expiration date of 02/13/2023.
The pt had a measles rash over entire body on 4/6/01. The pt had an MMR on 3/27/01.
Patient blood pressure was dropping and patient feeling faint and was experiencing numbness of hands and feet.  Started to feel swelling in mouth, administered epi-pen and called 911.   Patient went to hospital where it was determined that she did have a reaction.  They stabilized her and she went home that evening.  Followed up with patient the next day and patient was doing fine.
pt in facility, positive COVID test on 1/20/22 in facility; DNR; transitioned to comfort measures; pt passed away in the facility
Developed myalgias, subjective fevers, redness at injection site (L deltoid), then erythematous papular rash across upper back without vesicles or pruritis.
TOOK A BIG MEAL PRIOR TO TAKING VAXCHORA; This spontaneous case report (PVX2019-1674) was received from a pharmacist on 27-Jun-2019. It describes a 61-year-old male consumer who "took a big meal prior to taking Vaxchora" (product administration error). He was receiving Vaxchora for an unknown indication.  Case report: The consumer had a big meal prior to taking Vaxchora. He took a dose on 26-Jun-2019.  Action taken with Vaxchora with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a big meal prior to taking Vaxchora" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a big meal prior to taking Vaxchora" was considered as not applicable.
Child @ school - lunch lips turned blue unresponsive/non-verbal weak on (L) side observers  described the event as a seizure.
shingles, and other zoster-related conditions; shingles, and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided).  On an unknown date, the patient was treated by a physician for shingles, and other zoster-related conditions and due to the events was hospitalized. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent  conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered.  Causality assessment was related.
9x9cm erythemous indurated area circling immunization site, left thigh. Cellulitis. Rx'd with Cephalexin 250 mg/5ml 1.5 tsp TID for 7 days and OTC Benadryl.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number and exp date not reported), via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first Covid vaccine and on 26Dec2020, tested positive for Covid. Patient asked when if it was safe for her to get second dose. Asked if she get it on 21 days or if she had to wait. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Died unexpectedly in my arms.  On the 15th. Could not breathe   We tried to use inhaler and did not work.
This case is linked to 2013-09758 and 2013-09796 (Same patient). Initial report received from a non-healthcare professional (patient's parent) on 23 September 2013. A 06-month-old male patient had received a dose of IPOL, a dose of Hib vaccine (unknown manufacturer), a dose of DTaP (unknown manufacturer) and a dose of "RV" (unknown manufacturer) (batch number, dose number, route and site of administration were not reported for all vaccines), all on an unspecified date. The patient experienced reaction after receiving DTaP, RV, HIB and IPOL vaccine at 02 and 04 months age with crying for days (Details were not provided). The patient's pre-existing physician diagnosed drug allergies, birth defects, medication conditions, concomitant medications and illness at time of vaccination were not reported. On an unspecified date, after vaccination, the patient experienced crying for days. The corrective treatments and laboratory investigations were not reported. The patient had recovered from the event on an unspecified date. Documents held by sender: none.
Heart pain; Blurry vision; Head numbness; Has arthritis and noticed the pain in their legs has worsen.; Headache; A spontaneous report was received from a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart pain, numbness in head, headaches, blurry vision and worsening of arthritis.  The patient's medical history was not provided. The concurrent condition included arthritis. No concomitant product use was reported   On 27-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving the vaccine, the patient had experienced heart pain, numbness in head, headaches, blurry vision worsening of leg pain due to ongoing arthritis.  Treatment information included tylenol and ibuprofen.  Action taken with mRNA-1273 was unknown..  The outcome of the events, heart pain, numbness in their head, headaches, blurry vision and worsening of arthritis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient states arm hurts and hard to lift. Recommended waiting and if gets worse to talk to Doctor. Did recommend in separate arms at time of administration but patient insisted wanted one sore arm and not two. Did say would be more sore.
Pt had flu shot to the left deltoid on 11/2/17. The following day he developed a vesicular rash that started on the left deltoid and then spread to involve the left mid volar forearm and left thenar eminence, He described  the vesicles are tense and painful. He was seen at our office on11/09/2017.