chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023; No adverse event; Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient), PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.   Concurrent medical conditions included Essential hypertension, Chronic kidney disease and Benign prostatic hyperplasia.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient), PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient).    No concomitant medications were reported.  No treatment information was provided.
Within 5 minutes of vaccine administration patient complained about feeling dizzy. Patient became pale, appeared lethargic, felt clammy, dizziness, weakness, and threw up 3 times immediately. Patient was sitting in the chair, ice pack was applied to her neck and head, legs were elevated with a chair. Patient's blood pressure was taken after vomiting and was 60s/40s. Patient continued with the symptoms noted previously. Nurse assessed patient and administered Epipen 0.30mg.  Blood pressure was taken again, 100/60, 911 was called and patient was taken to near by hospital, guardian left to meet at the hospital.
Patient developed cough and fever post 2nd covid shot. Patient was seen at MD office 2 weeks after shot and was sent to hospital for worsening Transaminasemia and newly developed Thrombocytopenia (CMS/HCC).
pt recv vax 1MAY98 & 4MAY98 began exp diarrhea et. vomiting but was afeb;8MAY98 pt taken to clinic w/sz, released to home when exp yet another sx 9MAY98 returned to clinic was hosp x 1wk for sz;
his is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: ER8729), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 32030SD) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 04B621A), in left arm and on 12Oct2022 as dose 5 (booster), single (Lot number: 059F22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown", described as "vaccine brand: Pfizer / BioNTech, vaccine dose number: 3/ vaccine brand other: Moderna, vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.
lose his life after the vaccine; Passed out; swelling and pain in his side of his arm; swelling and pain in his side of his arm; asthma trigger; allergies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history included bad allergies and has asthma. Concomitant medications were not reported. He lose his life after the vaccine in Apr2021. He took the vaccine in Apr2021. After 3 days he took the vaccine on Tuesday, then Friday he was gone, that first dose. That day he died, he had like the asthma trigger like 10 minute after then he passed out but Thursday he was saying that he had like swelling and pain in his side of his arm. He had night shift and then morning came, Friday came home and then he ate and then he slept and then he woke up at 10 am just to go to kitchen and thought he was saying like having had allergies and 10 minutes then he passed out and then that was it. The reporter was just wondering how come, he still passed. Seriousness for lose his life after the vaccine was reported as death. The outcome of event lose his life after the vaccine was fatal and other events was unknown. The patient died in Apr2021. The cause of death was unknown. It was unknown if an autopsy was performed.  Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: lose his life after the vaccine
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the freezer.  Multiple patients received vaccine  that underwent a temperature excursion in the freezer. Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2016, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 2017, the patient was treated by a physician for shingles (Herpes zoster). As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events vaccination failure, emotional distress, Herpes zoster, pain and injury was unknown. Causality assessment was related.
Got fever on the following day 4 am. Body ache sore, fever temperature 99.7F. Took 400mg of ibuprofen and went back to sleep. Fever diminished in the morning. In the early afternoon  on the same day. Right top Lips got very swollen, seems like a delay allergic reaction. Didn?t intake anything unusual. Took one Claritin. Symptom persist. 9pm, lips swollen Is lessen but still persist.
8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM:  Reported tingling in fingers of right hand and burning of throat. CRNP notified and came to assess patient. Patient reported tingling in fingers of right hand but rest of right upper extremity felt fine. Having "upset stomach" and "throat soreness" which patient states she did not have prior to vaccine. She then stated her throat was burning. Able to drink water. Denied difficulty breathing or shortness of breath. Patient listed her allergies of Morphine and Percocet causing itching and scopolamine patch causing delirium. She reports taking all her prescribed medications this morning as well as 2 Tylenol.  9:29AM: Benadryl 25mg PO administered and patient continued to be monitored in observation area 9:44AM: CRNP reassessed patient and she stated she feels better and her throat was only sore and no longer burning 9:58 AM: CRNP reassessed. Patient states she is still feeling okay and would like to leave. MA walked with patient outside where patient got a taxi and was staying at her daughters house the rest of the day so she would not be by herself.
This case was reported by a other health professional via sales rep and described the occurrence of confusion in a 85-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HIGH-DOSE for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX and FLUZONE HIGH-DOSE. On 14th September 2018, less than a day after receiving SHINGRIX and FLUZONE HIGH-DOSE, the patient experienced confusion. On 15th September 2018, the outcome of the confusion was recovered/resolved. It was unknown if the reporter considered the confusion to be related to SHINGRIX. Additional details were received as follows: This case was reported by a Certified Medical Assistant (CMA). The patient was in clinic and received a dose of SHINGRIX and high dose flu vaccine during the same visit. Later that day, the patient's daughter reported that her mother showed signs of confusion and wanted to call her deceased husband. The reporter said that the patient was not confused the next day and was normal since. On 20th November 2018, the patient was in clinic for regular checkup and showed no signs of confusion and acted normal. The CMA was made aware of the initial patient response at her visit today. The patient and healthcare professional (HCP) wondered if the patient should get the second SHINGRIX dose. The reporter agreed to receive follow up from GlaxoSmithKline. It was unknown if the reporter considered the confusion to be related to FLUZONE HIGH-DOSE.
COVID positive on rapid test, symptomatic - body aches, headache, head congestion, cough, loss of taste and smell, fatigue Narrative:
I got congestion, cough, no fever, I went to pharmacy, and I tested positive for COVID-19. they gave me Paxlovid, and I felt better, but one month later I had congestion, cough, sore throat and I called my doctor, and told me it was rebounded COVID-19.
achy; it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).; joint aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired). At the time of the report, PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported. Treatment medications were not reported. She had reactions to the previous doses. She mentioned patient daughter got 3 Pfizer vaccines and had really bad reactions. She woke up screaming several times and got COVID shortly after.   This case was linked to MOD-2022-533467, MOD-2022-533335 (Patient Link).
Patient has red rash on arm below injection site that is itching. Patient is going to try cool compress and an oral antihistamine. She may also try a topical hydrocortisone cream. Patient will follow up with her primary care provider if these do not start to resolve rash.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 61-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the firs time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [batch number: 252230, route of administration: intramuscular, anatomical location: left deltoid, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805510 was crossed linked to original case 201804863 due to same reporter.
Patient back in with tongue itching and we gave her 25MG of Benadryl - patient sat for 5 minutes.  Breathing got more difficult and some throat swelling.  Spoke to patient and provided EPI PEN.  Patient sat for another 5-10 minutes said that condition was getting worse - trouble breathing, thickening of the throat.  Administered 2nd dose of EPI PEN - called 911.  EMT came within 10 minutes and took over care.  Patient left with ambulance.
receive next dose on day 6 (not day 7); 3rd dose on 17OCT2020 (which would have been day 22 from day 0 dose; This case was reported by a pharmacist via licensee and described the occurrence of drug dose administration interval too short in a female patient who received Rabies NVS (RabAvert) (batch number ARBA731B, expiry date unknown) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) (batch number ARBA731B, expiry date unknown) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 1st October 2020, the patient received the 2nd dose of RabAvert. On 17th October 2020, the patient received the 3rd dose of RabAvert. On 1st October 2020, unknown after receiving RabAvert, not applicable after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not provided. It was reported that patient for pre-exposure prophylaxis and it should be given 0, 7, 21 or 28.  It was reported that the patient received a shot on day 0 (batch number ARBA731B, expiry date unknown) and they received next dose on day 6 (not day 7) which led to shortening of vaccination schedule. The reporter asked if the does that count or they need another 2nd dose? He also stated that the patient received 3rd dose on 17th October 2020 (which would have been day 22 from day 0, instead of day 21, which led to lengthening of vaccination schedule. The patient did not experienced any adverse event.
8.18.2021 - 3:00pm metal taste in mouth - 10:00pm severe head pressure/head ache- extremely weak and lethargy/could not  get out of bed.   8.19.2021 - 6:30am called in sick from work - problems with vision -had hard time texting to my boss to call in sick/extremely weak and fatigue/sick/ could not lift head off pillow/fever symptoms/severe head pressure and pain. 8.19.2021 - 2:30pm - started taking advil and tynelol and aspirin.  felt a little better with medication, but once the medication was wearing off felt extremely bad again. 8.19.2021-8.24.2021 - fever symptoms- chills - headache /pressure- brain fog-muscle pain- winded/weakness-vison problems- loss of appetite-fatigue-stomach ache-leg cramps-insomnia. Continue symptoms and time frames  8.24.2021 -Care Now due to my continue symptons.  PA instruced me to return if symptoms did not totally improve - case was still open. PA released me back to work for 8.25-2021.  8.25.2021 Worked - head pressue - fatigue- weakness-muscle pain- winded/weakness 8.26.2021 - called in sick - vision problems - vertigo - head pressue- fatigue - weakness - muscle pain 8.27-2021 - called in sick - went back to Care now due to still having symptoms - winded/weakness - headache - felt better but still active symptoms. 8.28.2021  - 8.31.2021  - noticed harder to breathe/ very winded/short of breath-weakness- muscle pain - headache - chills 9.1.2021 - went to doctor - diagnosed with pneumonia - chest x ray - lab work to check for blood clots -  9.8.2021 - chest x ray - lungs good - no blood clots -still weakness/fatigue/muscle pain 9.9.2021 8:30pm - noticed right muscle soreness from neck to shoulder and slight shoulder pain- muscle weakness - numbness in right arm - fingers tingling 9.10.2021-9.13.2021 extreme right shoulder pain - very sharp pain - right arm numbness- hard to lift anything with right arm/or make a fist- fingers tingling-  trouble sleeping due to the pain. 9.14.2021 - severe right shoulder pain/could not use right arm due to numbness and pain/dizzy/veritgo/thought i was going to passout/joint and muscle pain moved to left shoulder,neck and lower hip.  9.15.2021 doctor appointment to get muscle and joint pain treated.- still active symptoms - further test for treatments.
got the vaccine shot years ago and ended up with the shingles/ Suspected vaccination failure; Shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine shot years ago and ended up with the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that he or she got the vaccine shot years ago from reporting and ended up with the shingles and it was so painful. The reporter reported that it was so painful that he or she would never get another vaccine shot ever again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
Pt received Anthrax #5 within one hr of immunization he started feeling warm, flushed and nausea. At time he was ashen and clammy and vomited 4 times.
Pt noticed local erythema <40mm along with heat in affected area.  No SOB.
PT HAD REDNESS, SWELLING, PAIN AND HEAT BELOW INJECTION SITE
While administering the second dose of the Jynneos vaccine to the patient the needle disconnected from the barrel which cause the patient to not receive the complete dose. The dose was immediately repeated in a different location.
Ocular stroke. A black curtain dropped down over right eye. Went to ER on the 28th, and was admitted. Had a blood clot in the right eye. Carotid artery right side did not have stenosis, they do not know why she had a stroke.  Doctor can't say that it was caused by the vaccine. She now has a permanent blind spot in right eye.
This spontaneous report as received from a healthcare worker (the patient's father) via company representative refers to a female patient of unknown age. On an unknown date (approximately 3-5 years ago), the patient was vaccinated with the first and second dose of GARDASIL (dose, lot #, expiration date, route and site of administration were not reported). On an unknown date, after the second dose of GARDASIL, the patient started having seizures. The patient was treated with unknown seizure medication (and continued taking the medications at the time of the report). The patient sought medical attention, she was having follow up appointments with a physician. It was unknown if the patient was ever admitted to the hospital. The outcome of seizures was unknown. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, seizures were considered to be medically significant. Additional information has been requested.
The area of the upper arm under where the vaccinations were given was hardened, red, swollen, and warm to the touch. The area also itched. This was treated with OTC Benadryl and Cortisone 10 cream. Symptoms are starting to improve per patient.
Chills, fever, muscle aches starting approx. 18 hours after shot. Resolved 36 hours after shot.  Unexpected menstrual bleeding starting approx. 24 hours after shot - medium flow and then spotting. Normal period had ended 3 days prior. Resolved approx. 48 hours after shot. Have been using Liletta hormonal IUD for 4 years.