chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited valid non-serious case received from a nurse on 20-Sep-2018. This case is linked to 2018SA266205 (same reporter). This case involves a 60 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot UJ004AB via unknown route in the left deltoid) instead of FLUZONE QUADRIVALENT on 15-Sep-2018 instead of FLUZONE QUADRIVALENT vaccine. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (it was reported that a 60 year old patient was vaccinated with FLUZONE HD). It was not known 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.
2/6/21 - flu like symptom x 24 hours.  2/12/21 - 2/13/2021 fAciAL Nerve INflAmAion R side of fAce.
Patient is a 35 y/o MALE with a pmh Desmoid tumor of T spine dx  2007 s/p resection and XRT, last chemo 2017, followed by HEME/ONC last seen  3/22/21. Presenting for bloody cough x1 day.  States was in usual state of health. Around midnight of day of presentation,  pt. was awoken from sleep by hard cough. He noticed that he was coughing  bright red blood, small volume but could not quantify. He was concerned  however did not immediately worry because he otherwise felt fine. Later that  afternoon, he had another episode of cough, this time darker in color and  "thicker". This being new and the second time, prompted pt. to present to ED.  While on his way here, he said he cont. to have cough with blood, small  volume but frequent, states "training blood all the way here". Denies any  prior similar event, no trauma, no recent illness, no sick contact, lives  alone, no recent travels, no prolonged immobility, no recent surgeries, no leg  pain/swelling. Of note, pt. received Moderna COVID-19 vaccine #2 on Wed of last  week (4/28/21).  ED Course: Pt was afebrile, initially tachycardic to 106, otherwise hemodynamically  stable. Labs: BMP wnl, no elevated wbc, h/h-15.4/46.1, coags normal on  admission. CTA w/ acute pulmonary emboli and left main extending into the  lingulae and left lower lobe segmental branches, in addition to Nonspecific  sub-5 mm pulmonary nodules; largest 5 mm nodule in right upper lobe. Pt  started on hep drip.
Narrative:  Patient reported a fever up to 101 degrees Fahrenheit, body aches, diaphoresis 3 days after the first dose of the COVID-19 vaccine was administered
Patient has a bruise at injection site, and also her arm was red and itchy for most her upper arm. She followed up with MD 3/16/15 at her normal check up and he told her that he would give her antibiotics if it appeared to be not getting better. Today 3/17/15 I was notified and she was prescribed doxycycline.
Expired Bexsero administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB27AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The information about the event and scenario was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was accidentally given dose of Bexsero, which led to expired vaccine used.
06-09-21 - Received send Dose Pfizer Co-Vid 19 Vac 06-10-21- Fever Chills Headaches 06-11-21-Heart Paint on and off during the day. 06-11-21- Urinating dark cola color and had small tiny red, look like small blood cloths 06-11-21 - Started having really bad anxiety 06-12-21- Anxiety continued, no more heart pain. 06-12-21 - Felt very exhausted
ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well.  Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well.  She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days.  There has been no diarrhea.  There have been no urinary symptoms.  3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis.  Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission.  Patient reports she has noticed increasing shortness of breath for the past several weeks.  She states the got worse around the noon time today.  Patient reports she began having some hemoptysis today.  Patient denies any chest pain or palpitations.  Patient denies any fevers or chills.  Patient denies any sinus congestion or nasal drainage.  Patient denies any headaches, myalgias, or loss of sense of taste and smell.  Patient does report a 4 day history of intermittent diarrhea.  She denies any nausea or vomiting.  Patient has had COVID-19 vaccination.  Of note, patient's family reports she has lost 10 lb in the past 30 days.  3/30/21 Deceased
This spontaneous report was received from an office supervisor  medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 (also reported as "since March 2017,") the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number: 4, vaccine brand other: Moderna;; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: CVS07462), in left arm, on 17Apr2021 as dose 2, single (Lot number: CVS07462), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: CVS7475) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: CVS3708), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had Gillian Barre as a child" (unspecified if ongoing), notes: Other medical history: Had Gillian Barre as a child. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Vaccine dose number: 4, vaccine brand other: Moderna;". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Oct2022) Negative, notes: Day 8 and 9 after starting Paxlovid I was feeling better and tested negative; (09Oct2022) Negative, notes: Day 8 and 9 after starting Paxlovid I was feeling better and tested negative; (10Oct2022) Positive, notes: Day 10 I was sneezing and felt "head cold" symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.
SCRATCHINESS IN THE BACK OF THROAT TREATMENT- 50 MG ORAL BENADRYL GIVEN FEELING FINE
A report has been received from a Pharmacist concerning a 61 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). The patient's concurrent disease(s) included testosterone deficiency. Concomitant medications included Testosterone propionate. FLUMIST QUADRIVALENT (INTRANASAL) started on 25-Jan-2014. The expired FLUMIST QUADRIVALENT administered to a 61 yo on 25-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered and expired FLUMIST QUADRIVALENT administered to a 61 yo is unknown. The report was considered to be non-serious.
on dialysis when received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (on dialysis when received the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 NO ADVERSE EVENT (on dialysis when received the vaccine). At the time of the report, NO ADVERSE EVENT (on dialysis when received the vaccine) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received contains significant  information  with regards to dose-2
Redness and hives local to shot and spreading to chest, face, and back, itching all over.
Non raised rash at injection area, torso and groin.  Noticed this morning 6/4/2021
Covid-19 like symptoms for 28 hours after injection. Chills, headache, muscle ache, fever of 101.7.  I had COVID in October and this was as bad as the worst day when I was positive.
Atrial fibrillation.  Afib occurs in the night preventing sleep. Afib confirmed with a personal monitor. I haven?t had significant incidence of afib in 6 months prior.  Afib started the night after the injection and the following 2 nights so far.  Periods of afib have increased in length (day 1 - 1 hour, day 2 - 3 hours, day 3 - 4+ hours).  Other effects were previously reported on this site. I didn?t initially make the afib connection since it wasn?t listed as an effect until I really looked for it specifically.  My afib is vagal type.
High blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, 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 HYPERTENSION (High blood pressure) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (High blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. On an unknown date, Fibrin D dimer: unknown (Inconclusive) unknown.  No concomitant medications were reported.   Patient ended up in the ER on 02-MAY-2021 where he reported a DIMER was done. They were able to get his blood pressure down after 2 different medications.  The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.  Company comment: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tinnitus.  Visited ENT and also diagnosed with eustachian disorder.  Treated with nasal rinses using xlear and prescription for Singulair.  Tinnitus remains.
No adverse effects; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-AUG-2019, the patient was vaccinated with improperly stored unspecified number of doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020 orally (dose was not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 24.1 degrees Fahrenheit for 4 hours 33 minutes. Previous temperature excursions included 34.7 degrees Fahrenheit for 3 hours 2 minutes. The data logger was involved.
The patient felt fine until approximately 7 hours after vaccine administration At that time he experience a rapid onset of headhace and lost of cognitive function. He describes his experience by stating he "could not understand what he was reading, he couldn't recall how to read even simple words, and couln't recall what simple objects like a mirror were called."  These syptoms remained for approximately 2 hours, then he took and Advil.  2 hours after the Advil, he states he returned to feeling normal with the exception of a headache.  He did not experience slurred speech or other symptoms of a stroke to the best of the patient's knowledge.  Upon awakening, he felt normal with the exception of the still present headache.
I felt ok after waiting 15 mins in the observation area and walked back to work. 6 mins into my walk to work, I start experiencing tightness and numbness on the left side of my cheek and lips. I went and spoke with my clinic manager and relayed my symptoms. She directed me to go back to the observation area and speak with someone. I walked quickly back to the hospital and reported to a nurse about the symptoms. She took my vitals and informed me that my temp was normal, but BP and pulse were high. After waiting approximately < 2 mins, BP  was taken again. Was informed I had to be taken to the ER to be evaluated. BP and pulse were taken again and no changes, numbess continue to remain. I was placed in ER room, and
ONE OF THREE CHILDREN WHO DEVELOPED BIG, RED, SWOLLEN AREA ON THIGH AND HAD FEVER FOLLOWING IMMINIZATION.  ALL THREE CHILDREN WERE IMMUNIZED FROM THE SAME VIAL.  VACCINE WOULD NOT DISSOLVE.
Stiff neck started after arriving home at 11:30 am Slept for four hrs due to not sleeping much the evening before 5:30 pm I noticed lymph swelling left side of my neck where stiffness notes earlier I took Tylenol  500mg at 10:00 pm  Because of NHL I thought I should advise you of this side effect
symptoms started 9/23 with nausea, vomiting, fatigue. tested 9/24 admitted to hospital 9/24
low grade fever 4OCT95-swelling @ site (lt deltoid) 4" xx 6" & w/compresses did not lesen until on 9OCT95;13OCT94 red-rash, oozing pussy like running;t101, coughing @ noc
The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023; No adverse event; Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M to 5Y dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the intact carton monovalent 6M-5Y vial of unknown size was administered to patient on 02-Mar-2023. The vial was not exposed to any temperature excursion.  It was also reported that the doses were administered to 6 patients as 1 dose on 16-Feb-2023, 2 doses on 02-Mar-2023 and 3 doses on 09-Mar-2023. The vial was initially stored in refrigerator on 1 vial on 16-Feb-2023, 1 vial on 02-Mar-2023 and 1 vial on 09-Mar-2023. The dose involved combination of first dose and some 2nd primary doses. Treatment medications were not provided.  This case is reported for patient 2 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-715544, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715551, US-MODERNATX, INC.-MOD-2023-715548 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715544:Patient 01 (Master case) US-MODERNATX, INC.-MOD-2023-715550:Patient 3 US-MODERNATX, INC.-MOD-2023-715549:Patient 4 US-MODERNATX, INC.-MOD-2023-715551:Patient 5 US-MODERNATX, INC.-MOD-2023-715548:Patient 6
Vaccine administration error: Adolescent was 16 yrs old when first dose was given.
Patient reported not feeling well.  Staff at the facility checked her blood pressure and it was high.  911 was called and paramedics determined patient was fine.  She was not taken to the hospital.
Right after getting the vaccination shot, I had a tingling in my face and base of my skull. It felt like steel wool scratching my face. I my lips, tongue and face are numb. When I got home, I took my migraine medication, it did nothing to help lessen the pain, it just gradually got worse. I called my neurologist to go in and get I.V. medication to help break the migraine. I am currently awaiting the doctor to call me back to get me into her office. I have taken a MEDROL DOSEPAK to try and get the pain to lessen but this has not helped.
Client reports she developed a rash under her breasts, at elbows and in groin, 3 or 4 hours, post vax. She continues to have rash.
weakness, SOB, +COVID (on decadron, hold remdisivir), pancreast duct adenocarcinoma. needs whipple procedure - cancelled due to +COVID test. . peritoneal dialysis. diarrhea off and on. No O2 required initially. O2 to 3L on 1/29. O2 levels continue to increase. At 7L on 2/2.  on 2/5 O2 down to 5L NC ( in addition to 12 L oxymask with ambulation).  new onset jaundice. Increased labored breathing. RRT called, placed on BIPAP, Intubated, palliative care. WBC up to 20.37. Patient continued to decline. His vasopressor requirement progressively increased, and he went into severe sepsis profound shockFinally on 02/19/2022 he required 3 vasopressors and continued to decline. patient's family decided for DNR.
At 4am, I woke up with a high fever (which I expected).  I got up to eat a piece of toast before I took Tylenol.  I ate about 2 bites of the toast and started sweating profusely.  Fortunately, my husband had gotten up at that time to help me out.  At about that time, I totally passed out (fainted).  According to my husband, I was out about 10 seconds.  I woke up to him panicking and on the verge of calling 911.  I was extremely weak and could not walk without his help.  I did not end up taking Tylenol since I could not keep anything down (I ended up with the dry heaves).   The "passing out" side effect is not listed on the side effects.  My daughter said her brother-in-law also passed out several hours after taking Moderna.  I experienced all of the side effects listed:  fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, fever, dizziness and weakness.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2, single (Lot number: FF 2593), in right arm and on 29Apr2022 as dose 3 (booster), single (Lot number: FJ 4989), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 01Apr2021 as dose 1, single (Lot number: 1805031), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Arthritis" (unspecified if ongoing); "irritable bowel" (unspecified if ongoing); "lower back pain" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive; (19Jul2022) Positive; (25Jul2022) negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound. Covid symptoms started 19Jul22. Positive PCR test same day. Started 5-day course of Paxlovid 20Jul22. Covid Symptoms greatly improved after 48 hours. Finished full five-day course. First negative rapid test on 25Jul. Felt fully recovered by 28Jul and rapid tested negative again. Started feeling sick again, 30Jul. Rapid test positive. Still sick and testing positive as of today 03Aug.  No follow-up attempts are possible. No further information is expected.
Patient had a fever for 3 days after shot. He went to ER and they then diagnosed him as having sepsis. He had to have an IV pick instilled into his arm and received antibiotics continuously until January 2022
Rash on both arms and on chest. I am not sure if this is from the vaccine or from the Liver Disease.