chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 65 y.o. male with a history of permanent A-fib, on warfarin, COPD, history of prior strokes without deficits who presented to RMH 9/16/2023 with left-sided weakness. Found to be COVID positive.   1. Suspected CVA: Concerning for TIA/stroke.  Symptoms for 3+ days.  CT head 9/16/23  nonacute. Unable to obatin MRI due to pacemaker. Repeat CT nonacute. LDL 32, A1c 5.9 on admission labs.  Continued warfarin, aspirin.  Pharmacy dosed warfarin. Daily.  Switched to Lipitor. Neurology followed. 2. COVID-19 infection:  Presented with cough, loss of taste/smell.  X-ray 9/16/2023 without focal infiltrates. Symptomatic for 5 days before testing l.   Does not meet criteria for treatment at this time except for  steroid for mild hypoxia.  Continued on dexamethasone 6 mg daily as off oxygen so discontinued at discharge..  Supportive treatment. 3. Acute hypoxic respiratory failure: Patient is on 2 L oxygen at home on as-needed basis.  Here patient is on 2 L oxygen 24/7.  Started on dexamethasone for hypoxia secondary to COVID.  No need for other therapy  as patient is symptomatic for more than 6- 7 days before getting tested. Weaned off oxygen at discharge. 4. Hyperkalemia :potassium 5.3 on 9/23.  S/p  hyperkalemic cocktail.  Will monitor potassium,   Continued to hold lisinopril.  Potassium 5.1 on 9/2423.  Stable at dc. 5. Metabolic alkalosis: Bicarb 38, likely in setting of Lasix. Held  Lasix on 9/24.  Trended down. stable. 6. Leukopenia, thrombocytopenia: WBC 1.32 and platelets 81 on 9/20.  Hematology followed.  Likely secondary to COVID-19.  WBC and platelets trended up with WBC 9.32 with platelet 202 on 9/24. Resolved. 7.  CAD: s/p RCA stent in 2004 and RCA / OM stents placed in 2013. Follows with cardiology. Echo 7/11/23 EF 55-60%.  proBNP 1539. Troponin negative x2. Continue aspirin/statin, Lasix, lisinopril, 8. Permanent  A-fib: History of ablation, pacemaker in place.  History of mitral valve repair.  Echo 7/11/2023 with moderate mitral stenosis.  Continued home dose  warfarin, Continued metoprolol.  INR goal 2-3.  9. H/O mitral valvuloplasty: at the age of 9 due to rheumatic fever.  10. History of prior strokes: CT head with small chronic lacunar infarcts in left frontal lobe.  As above. 11. COPD: On room air.  Continue home inhalers 12. Hypertension: Controlled on admit.  Continued home meds. 13. tobacco abuse: Recommend cessation.   14. Chronic pain: data reviewed.  Home meds continued,Lyrica and Percocet. 15. Code status: DNR CCA
This spontaneous report as received from a registered nurse refers to herself: a 62 year old female patient. Her medical history included unspecified reaction to FLAGYL. On 17-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date not provided). Concomitant therapy included unspecified antihistamine drugs. On 17-MAY-2012, the patient experienced a small, rectangular shaped rash at the injection site which was about 1.5x3 cm. There were no lab diagnostic studies performed, and no treatment was given for the adverse event. On an unknown date, the patient recovered from the injection site rash. The patient did not seek medical attention. The relatedness between adverse event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
LITTLE SIDE EFFECTS; This spontaneous report received from a consumer via a company representative from social media concerned multiple patients. 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 numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced little side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20220216041. This case, from the same reporter is linked to 20220210428 and 20220216024.
Patient brought to the ED by EMS for evaluation of excessive sleepiness on 11/16/22. His living facility became concerned when he could not stay awake that day. COVID-19 PCR test was done which resulted positive. Ultimately, patient admitted 11/16/22 for further management of respiratory failure likely related to COVID-19 infection as well as chronic conditions of OSA (on CPAP) and morbid obesity. He was placed on BiPAP initially, however oxygen needs improved during his hospitalization. He was able to be weaned down to his baseline supplemental oxygen need of 2L. Patient improved and was discharged 11/21/22.
27Apr90 pt vax;  19May90 devel rash then fever for 2 days.
Localized reaction at vac site. Redness 3x6. Rec TYLENOL, MORTIN, BENADRYL.
Pt reported to the Immunizations clinic on the 30 April 2007 and stated she had noticed a bloody discharge from her nipple and wanted to know if that was a side effect of the smallpox vaccine. I asked If she was still having the discharged and she stated no, she just noticed it one time. I told the patient to have a seat and talked to doctor about the issue. He advised me to let her know that we hadn't heard of this, nipple dischage, being a side effect of the smallpox vaccine, but it is common to have swollen lymph nodes under the arm. He advised me to have her to make an appointment with her PCM to find out what was going on. She made an appointment and was seen the same day. An U/S was ordered. Patient did not complain if discharge when she came in on 4/25/07 for her smallpox recheck.
super high blood pressure; extremely dizziness; nausea; chills; fever 103F; threw up; headache; body ache; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (super high blood pressure), PAIN (body ache), DIZZINESS (extremely dizziness), HEADACHE (headache) and NAUSEA (nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up). On 10-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (super high blood pressure), DIZZINESS (extremely dizziness) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency and TIZANIDINE for Dizziness, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (super high blood pressure) and DIZZINESS (extremely dizziness) had not resolved, PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up) had resolved and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 103°f (High) 103°F. On 10-Apr-2021, Blood pressure measurement: super high (High) super high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was on an unspecified blood pressure medicine as a concomitant product. Patient went to primary doctor, cardiologist, ENT and neurologist.
About 1-1.5 hours after the injection, my daughter experienced lethargy and sleepiness. She slept for several hours. She also experienced localized soreness at the injection site for a few days. The day after the injection, she had a headache for most of the day.
Child got her 2nd Rotavirus on 10/10/13 and began vomiting that evening, that turned into bile vomit. She was admitted that evening with an ileus at Hosp.
I have grown up getting cold sores (HSV-1) about twice a year at most. Now since getting vaccinated, I got one in March, June, July, September, October, and now November of this year!
pt states that arm became red, swollen, itchy from shoulder to elbow on the 25th;no SOB;lasted approx 10 days;
Patient was given a state purchased pediatric dose of Hepatitis B vaccine, instead of an adult dose.
48 hours notices bumps in the rear of tongue, did not affect swallowing or breathing however, over time they did get larger. By 96 hours after vaccination, there was an uncomfortable feeling in my throat as I was breathing which lasted consistently for about 24 hours. Which in that time, I was able to get into contact with health care professionals (Dentist and Ear Nose Throat Dr. )  Who suggested Benadryl, contact PCP, and make sure to have EPI pen.  After taking benadryl for 12 hours, it seemed to have gone down. 6 days after vaccine (day 5 was a holiday), I was able to have a TeleMed appointment with a PA, spoke with my PCP.  Day 8 I was able to see my doctor who confirmed it was an allergic reaction and prescribed a steroid to help my throat/tongue to continue to go back.
This spontaneous report as received from a Certified Medical Assistant refers to an infant of 13 days old at the time of the report of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administered a dose of (Oka/Merck) VARIVAX, subcutaneous injection (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR#1505USA013644, MARR#1505USA013645, MARR#1505USA013646. Additional information has been requested.
94 yr old fully vaccinated (3 shots) patient present back to the ED after his son states he got him home and he was too weak to ambulate on his own and noted his pulse oximetry was low.  Began having sore throat and drainage w cough 1/31, then developed fever that next am. Son states the patient does not leave his home and he and other family members have had mild URI symptoms for a couple weeks so they are getting tested, assuming they gave it to him. CXR does not look bad but paO2 is <60 and looks ill. Was prescribed Paxlovid last night but son has not filled yet.  1. Acute respiratory failure with hypoxia  2. Pneumonia due to COVID-19 virus  3. Acute delirium, acute metabolic encephalopathy  4. Fever and chill  symptoms 1/31 and febrile so pretty acute    fully vaccinated CXR not bad started Dex, RDSV - both completed day 3 on 2/4  - considered initiating IL-6 inhibitor if O2 needs increasing but is now on room air will not continue RDSV or  Dex as room air and any risk > benefit at this point 5. HTN resume his ARB and amlodipine at higher doses   PT recommended SNF but also acknowledges he has a very supportive family in the the home  He has no interest in SNF and he and son both feel they can manage at home
The Moderna triggered a severe and debilitating  flareup of my Hashimotos.  There really is no medication to treat this condition other than a gluten- free diet and supplements.  I am reporting this because the vaccine triggered an existing autoimmune condition.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 29-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
diagnosis with COVID 19, COVID positive after taking the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosis with COVID 19, COVID positive after taking the 1st shot) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced COVID-19 (diagnosis with COVID 19, COVID positive after taking the 1st shot). At the time of the report, COVID-19 (diagnosis with COVID 19, COVID positive after taking the 1st shot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: (Positive) Positive-detected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Date of SARS-CoV2 testing was provided.; Sender's Comments: Based on mechanism of action of mRNA 1273 and etiology of event Covid 19, event is unlikely related to the vaccine.
Low pulse Rate, Left arm Limp, malaise after flu shot. Seen by primary MD who sent patient to ER for eval Patient is employee of hospital. Received flu shot 10/17/19 @ 0630. Reported malaise and Limp left arm. Sent to his primary care physician who sent him to the ER for evaluation of Low pulse.
Nodule at injection site, size is half an orange, slightly increased in size; Fatigue; Vx administered subcutaneously; Injection site nodule is warm; Injection site nodule is red; Injection site noduleTender to touch; Injection site raised; This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 19th October 2022 received 1st dose).   On 19th January 2023, the patient received the 2nd dose of Shingrix (subcutaneous). In January 2023, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site tenderness and injection site swelling. On 19th January 2023, the patient experienced injection site nodule, fatigue and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was the patient.  The reporter reported that patient received Shingrix at a local pharmacy.  The reporter reported HCP admitted to administering dose subcutaneously, instead of intramuscularly.  The patient experiencing fatigue and a nodule at the injection site which was warm, red, raised, and tender to touch.  The reporter reported nodule was approximately the size of half an orange.  The reporter reported fatigue and nodule began last night, between 11pm and 12am. The nodule had slightly increased in size since onset. The reporter wanted to knew would the dose need to be repeated or any efficacy on subcutaneous versus intramuscular injections. The patient unable to provide lot number and expiration details of vaccine. The reporter consent to follow up. Additional supportive information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The case US2023008745 is identified as duplicate of case US2023008742.  All future correspondence would be added in case US2023008742, which stands as case of record for this patient and the case US2023008745 would be deleted.
1st dose on 13Mar2023, 2nd on 03Apr2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number TY2TY, expiry date 09-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 03-APR-2023, the patient received the 2nd dose of Shingrix. On 03-APR-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: 1st dose on 13Mar2023, 2nd on 03Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
1st dose  2 years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose about 2 years ago in 2021).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 08-Feb-2023. Reporter's Comment: The patient did not remember the exact date of the first vaccine and did not know which brand he received. The patient did not get the second dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of Hepatitis A vaccine, which led to incomplete course of vaccination.
soreness in the arm; Ringing in the ears; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears) and PAIN IN EXTREMITY (soreness in the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced TINNITUS (Ringing in the ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, TINNITUS (Ringing in the ears) and PAIN IN EXTREMITY (soreness in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; 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.
Nausea; Body ache; Tiredness; Headache; Feeling unwell; Left arm swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: unknown) in the left arm on 20Feb2021 as single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 11:45, the patient experienced nausea, body ache, tiredness, headache, feeling unwell and swollen lymph nodes in left arm. The clinical outcome of the events nausea, body ache, tiredness, headache, feeling unwell and left arm swollen lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient's information, updated first dose bnt162b2 as historical vaccine, updated concomitant therapy and amended narrative.  No follow-up attempts are needed. No further information is expected.
Influenza Qudrivalent preservative free (unknown brand) was given in left arm - no soreness. Right arm sore to touch and red/bruised like.  Woke the next morning with aches in hip and spread to entire body muscle aches, chills and likely a fever - although never took temperature.  Chills/aches lasted until about 8PM with little to no relief with acetaminophen once mid day and ibuprofen late afternoon.  Evening tired and developed nausea that lasted most of the following day.  All symptoms except soreness resolved on Sunday October 14th.  Soreness gone by Tuesday October 16.