chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Collapsing glomerulopathy; membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) in a 26-year-old female patient 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHROPATHY (Collapsing glomerulopathy) (seriousness criterion medically significant) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: glomerular disease biopsy-proven glomerular disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHROPATHY (Collapsing glomerulopathy) and GLOMERULONEPHRITIS MEMBRANOUS (membranous nephropathy) to be related.    Concomitant and treatment medications were not reported.  It was reported that the patients with collapsing glomerulopathy were of descent and had two APOL1 genomic risk alleles.  Company Comment: This literature-non-study case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of collapsing glomerulopathy and membranous nephropathy (biopsy-proven glomerular diseases) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-539885, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This literature-non-study case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of collapsing glomerulopathy and membranous nephropathy (biopsy-proven glomerular diseases) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
The first reaction was the same day on the second dose given on January 22, 2021 (Manufacturer: Moderna). Reactions were heart palpitations, high blood pressure, Shortness of breath, and tagitue.  The next day left neck nodule swelled and developed photophobia.  The consequence of the reaction was with medical provider with follow-up.   The second reaction event was the covid booster Administered on July 7, 2022 (Manufacturer: Pfizer,  Inc). On August 3, 2022. I had symptoms of Covid and experienced increased photophobia and fatigue.  September 2022-present and continue with follow-up with specialists ophthalmologist for Strabismus.
Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened.  Denied SOB and denied chest pain.  Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.
Public health nursing was conducting an outreach clinic. Client is an employee at the retirement center and received the Moderna vaccine via intramuscular injection to the left deltoid at approximately 0830. Client was instructed to wait 20 minutes before leaving. at approximately 0850 client came to nursing staff and reported hives to bilateral arms extending from elbow to wrist. No other hives present at that time. Client reported that they did not itch, and she only noticed them because she had looked down to get out of her chair. Client denied difficulty breathing or change to airway. Client reports that she "gets hives for everything."  HR: 62, BP: 150/82, Respirations: 14. DON at the retirement center gave the client a dose of Benadryl and Zyrtec @ 0857. Client stated she felt fine and wished to return to her work duties. on 12/31/20 I called client to follow up and had to leave a voicemail. Client returned call while I was unavailable and left a message with the office secretary stating she was feeling fine, and had no more hives. Call placed to client on 1/4/21. Client did not answer.
The patient called the pharmacy on 11-27-17. She said she has experience severe pain and stiffness in her right arm since receiving PNEUMOVAX. She also received the flu shot in her left arm on the same day and has no complaints. I recommended taking TYLENOL (she cannot take NSAIDs due to kidney problems) and ice. I told her to contact her primary care provider for further care.
Hospitalized 10/19/2021; COVID-19 positive 10/18/2021; fully vaccinated  CHIEF COMPLAINT: COVID-19 Assessment/Plan  COVID-19 pneumonia Acute hypoxic respiratory failure - Admit as inpatient, anticipating >2 midnight hospital stay. - COVID+ on 10/18, symptomatic since 10/16.  - Desaturating into 80?s on baseline RA, now on 2L. - CXR without e/o acute processes, noting only cardiomegaly. - Continue Decadron 6 mg daily x 10 days. - Consider remdesivir if O2 needs increase, infiltrates develop, and renal function allows. - Supportive care, symptom management, proning PRN, encourage IS/pulm toilet. - Monitor CPO and wean supplemental O2 as able. Acute encephalopathy-improving - Suspect 2/2 above, with no e/o acute process on CTH. - Hold potentially sedating home meds and avoid deliriogenic meds in hospital. - Treat underlying illness, regularly reorient, promote normal sleep-wake cycle. 10/21/21 note: CHIEF COMPLAINT: COVID-19   Assessment/Plan    ASSESSMENT / PLAN: Acute hypoxic respiratory failure COVID-19 pneumonia Chest x-ray without acute process Continue Decadron 6 mg daily Repeat CXR 10/20 no acute cardiopulmonary process Incentive spirometry CRP 45-- >17 Procalcitonin 0.09 D dimer 520-- > 340 Continue to wean down oxygen Tessalon TID Acute encephalopathy improved CT head no acute intracranial process 10/25/2021 note: CHIEF COMPLAINT: COVID-19 Assessment/Plan  Acute hypoxic respiratory failure resolved ( now on room air) COVID-19 pneumonia Chest x-ray without acute process Continue Decadron 6 mg daily Day 6 of 10 Repeat CXR 10/20 no acute cardiopulmonary process Incentive spirometry CRP 45-- >17 Procalcitonin 0.09 D dimer 520-- > 340 Tessalon TID Acute encephalopathy improved CT head no acute intracranial process PT/OT recommends SAR. Daughter updated 10/25.  Medically stable for SAR once placement arranged First eligible clearing 10/27
Had symptoms of a urinary tract infection for several days.  I eventually went to an urgent care and was prescribed an antibiotic (Amoxicilin-clavulanate) even though they tested a urine sample and it showed no sign of an infection.  Basically I had symptoms of a UTI without an UTI.
Initial information regarding an unsolicited valid non-serious case was received on 31-Jul-2018 from a consumer/non- healthcare professional. This case is linked to case 2018SA212249 (same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients past medical history, medical treatment, vaccination and family history were not provided. It was an actual medication error due to incomplete course of vaccination. It was reported that return home their preferred medical facilities did not have IMOVAX to finished their series. It was unknown whether the patient had any 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. List of documents held by sender: none.
PATIENT PRESENTED TODAY WITH RED BUMPS ON HIS FACE, BACK AND NECK.  HIS LIPS WERE SWOLLEN.  LOOKS LIKE ENORMOUS HIVES.  RED, ITCHY AND SWOLLEN LIPS.  NO DIFFICULTY BREATHING.  RECOMMENDED NOT GETTING SECOND SHOT, TAKING DIPHENHYDRAMINE AND FOLLOWING UP WITH PHYSICIAN IF SYMPTOMS DO NOT IMPROVE OR GET WORSE
Pain in testicles and prostate. Headache, fever, chills, fast heart beat, stuffy nose and sinus pressure, fatigue & insomnia.
The Moderna Bivalent product was administered as the 2nd dose in the 2 dose series, rather than the required Moderna Monovalent product. No signs/symptoms occurred as a result.  No treatment was required and the health status of the individual is the same as prior to the vaccine administration.
Pt. c/o cold symptoms, sore throat 4 days following high dose influenza vaccine.
This spontaneous report as received from a certified medical assistant refers to an 11 year old male patient. No information regarding the patient's medical history and concurrent conditions was reported. On 21-APR-2016 at 16:58, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the left arm, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs, or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of the several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
No additional AE reported; Healthcare provider reports administration of an expired dose of PNEUMOVAX 23 (prefilled syringe)  to a patient on 2/8/2023.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 08-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, lot number U026796 with expiration date 28-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered).  The reporter confirmed product was not involved in a temperature excursion and has been stored within recommended storage range until date of administration. No additional adverse event or product quality complaints reported.
Upper arm soreness, redness at injection site., headaches, fatigue, chills, fever, body aches.
missed his appointment because he fell and was in the hospital; illness which put him in (name withheld) hospital; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via intramuscular route on 14Jan2021 at 11:15 (Batch/Lot number: EL1284) as single dose for COVID-19 immunisation. The patient medical history included ongoing heart condition and depression. Concomitant medications were not reported. Upon follow-up (05Feb2021): The caller stated that her husband was supposed to get the second dose yesterday, but he missed his appointment because he fell and was in the hospital and asked for how long he can wait to get his second dose without having to restart. Upon follow-up on 26Mar2021, it was reported that the patient was unable to take the 2nd dose of Vaccine due to illness which put him in (name withheld) hospital on 04Feb2021. The patient was able to get the second dose 1 week later on 11Feb2021. The primary care physician informed the patient of the time allowable between doses. The outcome of the event was unknown.  Follow-up activities have been completed and information about lot/batch number has been requested.  Follow-up (26Mar2021): New information received from a contactable consumer includes: patient information (updated patient age and relevant medical history), product information (updated vaccine administration date and time, added lot number and route of administration) and event information (deleted the event missed dose, added new event ill feeling and updated seriousness to serious due to hospitalization).  Follow-up attempts are completed. No further information is expected.
p/vax pt devel itching  behind rt ear & swelling & drooping of the rt side of face;7/8/99 pt devel rt partial facial paralysis;tx w/pred, Valtrex;today has complete rt facial paralysis
patient received a second full dose of Moderna on 10/30/21 after receiving Janssen on 04/03/2021 and Moderna on 09/19/2021.
20 minutes after receiving flu shot, patient says she's feeling funny and asked for paramedics. She refused to leave with paramedics and stated she'll go to hospital with her husband.
Patient received Moderna booster shot 0.25ml  at 0852 on left arm. 20 mintues after patient experiencing numbness and tingling on left deltoid, travelling upward to left face. This RN arrived at 0920 and performed Befast. Negative BEFAST. 132/74 (95) P 85 RA 98% RR20. Pt was anxious about reaction. Dr arrived. Care handed off to RN.
Severe and Debilitating Abdominal Pain. Extreme sweating and Hot and Cold Temperature. Currently still feeling exhausted and slight body cramps
Headache chest pain, nausea, arm pain Narrative:  employee states the symptoms were not constant but sporadic throughout the day
This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with RECOMBIVAX HB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX23, PEDVAXHIB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001297 and 1211USA001298. Additional information has been requested.
This spontaneous report was received from a nurse referring to a 65 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAR-2018, the patient was inadvertently vaccinated with a dose of Oka-Merck PROQUAD (rHA), lot # N019250 with expiration date 20-DEC-2018 for prophylaxis instead of a dose of ZOSTAVAX (route of administration was not provided). Concomitant medications included sterile diluent. No adverse effect was reported. It was stated that the facility where the vaccine was administered usually stored Oka-Merck PROQUAD and ZOSTAVAX in the same container, but the nurse who administered the vaccine did not realize there was no ZOSTAVAX in that container at that time. The nurse then took a dose of Oka-Merck PROQUAD from that container without realizing it was Oka-Merck PROQUAD and did not notice this until after administration of the dose. The nurse who administered the vaccine stated that she knew the difference between both vaccines, but that she made a medication error.
01/16/22 presents to ED for "pain and bleeding from a wound under his tongue". PMHx of "excision of a tongue lesion" "A-fib (on Xarelto), hypertension, BPH, COPD, hypertension, and cancer status post resection, anxiety, depression and bipolar disorder"
Diarrhea, throwing up, dizziness, tiredness, trouble breathing, fever,- flu like symptoms
First does was on January 25th, 2021 (Pfizer, EL9262). Second dose was on February 19th, 2021 (Pfizer, EL9267). Felt fine with no issues until about 2-3 weeks later, a rash on my arm started to show up. It started circular in shape and was pearly white in the middle with a red on the outside of the circle and was raised like a welt. It started on the upper part of my arm and then spread across my shoulders and down my torso, but didn't go below my waist. My doctor said it was definitely a reaction to something. Right around the same time, they put me on a new medication (an anti depressant), so he told me to stop taking that and I did. It then continued to itch and the rash persisted for months and during that time, I went through two rounds of oral steroids and took multiple Benadryl a day to help with the itching and sort of quell the rash. I was then told I needed to see a dermatologist. When I saw them (this was 5 to 6 months post the initial reaction, they  only provided me some cream that didn't really work. Over the course of the first 1-4 months after the rash showed up (March to July), the rash changed from something looking like a mobilliform rash, to something that looked like shingles, then something that looked like pityriasis rosea, then eczema. But the time I got to the dermatologist, the worst of it had gone away. So she gave me a steroid shot and some cream (Triamcinolone Acetonide) and said if it didn't get better to call them back and they'd look at me again. I've called them but they haven't called me back, so I'm working with my PCP to see if they can refer me to someone else. I got my booster vaccine on August 20th, 2021 (Pfizer, EW0175) and now the rash is starting to return again, and I'm trying to get into my doctor but I am having difficulties doing so. Figured it would just go away, and it's persisted since the initial shots, but only in small places on my body. Currently, I have a breakout spot on my left bicep (close to the injection location), left hand, right forearm, my shoulders, neck, my right arm pit, and a small spot on my left hip.. The only two factors that changed during this past year was the COVID vaccine (which my booster is making it come back) and that new medication, which has been out of my system since march.
This spontaneous report was received from a physician via a company employee and refers to a 63 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-APR-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration date were not reported) for prevention of shingles.   On an unknown date in April 2017, the patient experienced bruising, redness and hardness at the injection site. The patient sought medical attention. No treatment was given for the adverse events. The outcome of the events of bruising, redness and hardness at the injection site was unknown. The relatedness between the events of bruising, redness and hardness at the injection site and ZOSTAVAX was not reported.   Additional information is not expected, because there was no consent to contact the reporter.
Soreness at site of injection - started 1 hour after injection progressed to firm nodule that was tender and warm. Resolved after 10 days. Headache on day 1 only. Soreness to neck on side of injection - resolved in two days. Fatigue - resolved in 2 days.
Currently she has a flare up of RA; This is a spontaneous report received from a Pfizer sponsored program via contactable Other Healthcare Professional. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 01Mar2021 at single dose for covid-19 immunization. Medical history included Rheumatoid arthritis. Concomitant medication was not reported. Reporter stated ""I am an Internist- part of the team treating a newly diagnosed Rheumatoid arthritis patient. She received her 1st of Pfizer COVID vaccine on Mar 1. Currently (Mar2021) she has a flare up of RA and has severe joint inflammation and pain. She was prescribed steroid medication to begin 2 weeks after the 2nd dose of COVID vaccine. But her inflammation, swelling and pain are severe. Please let me know what affect the steroids have on antibody formation to the covid vaccine, and the timing for 2nd dose."" The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known on available information and disease profile of Rheumatoid arthritis, the event Rheumatoid arthritis is not considered related to the using of BNT162B2 but more likely related to diseases progression.