chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 17-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA001261 US-009507513-1808USA004371.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2013, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
On 1/9/21 pt reported having headache on Saturday that was relieved with Tylenol. Then 2 days later swollen lymph node and has been taking Advil.
occasional cough; sinuses; congestion; Caller mentions that she got the first dose of the Pfizer covid vaccine on March 27th but was diagnosed with covid yesterday; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Covax . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient reported that, she got the first dose of the vaccine on 27Mar2021, but was diagnosed with COVID-19 yesterday (05Apr2021). She also reported occasional cough, sinuses and congestion on an unspecified date. Patient had an appointment to get on 17Apr2021, the second dose of vaccine and wanted to know if she can still receive the second dose of covid-19 vaccine after testing positive for covid-19 virus after first dose. All the events were considered as non-serious as reported. Outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Caller reports that he is scheduled for his second dose on 27Feb2021 and he noticed that it is 17 days in between first dose.; Caller reports that he began to get dizzy shortly after receiving vaccine; This is a spontaneous report from a contactable consumer. A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 10Feb2021 caller reports that he began to get dizzy shortly after receiving vaccine. Caller reports that he feels fine now. Caller reports that he is allergic to sulfa. Caller reports that he is scheduled for his second dose on 27Feb2021, and he noticed that it is 17 days in between first dose. Caller would like to know if that is okay. The outcome of the event dizzy was recovered and outcome of the event he noticed that it is 17 days in between first dose was unknown.  information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fevers from 02-03-2021 to current date of 10-20-21.  He would get a fever at least once or twice weekly and feel weak and tired.
Develop Covid illness 1/11/2022 at 3:00 a.m. Testing positive for Covid on 1/13/2022. Very ill for 48 hours. Then gradually recovered over another week.
Patient felt light headed and was vomiting. Patient was advised to lay down and given cold water.
This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1801USA002100: US-009507513-1801USA002098: US-009507513-1801USA002097: US-009507513-1801USA002099:
A report has been received from a Health Professional concerning a 14 out of 140 patient, who had been receiving Intramuscular FLUMIST, INTRANASAL), 0.2 Milliliters. Once/Single administration. FLUMIST (INTRANASAL) started on an unknown date. The patient experienced 14 PATIENTS TEST POSITIVE FOR INFLUENZA. The outcome of the event of 14 PATIENTS TEST POSITVE FOR INFLUENZA A was unknown. The report was considered to be non-serious.
hearing deficit / hearing loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,Single), for Covid-19 immunization; Bnt162b2 (Dose 2, Single), for Covid-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing deficit / hearing loss". The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: hearing loss.  Clinical information: I received your Covid "vaccine" in 2 doses, as well as 2 boosters. I have always experienced very acute hearing & have no family history of hearing loss. This past year my grandchildren brought to my attention, I have a hearing deficit. After an ear examination & hearing test by 2 doctors, I am now a prime candidate for hearing aids. In retrospect I believe I may have my hearing loss due to the boosters. No one could be sure. I feel this information is important for your records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The nausea and fatigue started around 11 AM on Friday, and I've still got the nausea. I also threw up Sunday around 6 AM
left side facial paralysis/left half of her face became paralyzed; numbness on the left side part of her face; her tongue is still numb; cannot blink her left eye; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route on 26May2021 (at the age of 37-years) at left shoulder as single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route on 05May2021 as single dose in the left arm for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not took any other products. On 07Jun2021, the patient experienced left side facial paralysis/ left half of her face became paralyzed which was facial paralyzed. It started to have numbness on the left side part of her face and it already went out since yesterday, but her tongue was still numb. She has been experiencing numbness but not painful. She also cannot blink her left eye. Patient stated that numbness went away but the look got worse and sometimes feels numbness but not all the time. Patient stated that she started drinking B complex vitamins yesterday. She wanted to know if this was a recorded side effect of the vaccine and if she needs to see a doctor for treatment. Patient stated that she just searching online probable connection to Pfizer and facial paralyzed and saw there were some studies that connected the two. The patient did not went to Emergency Room. Patient stated she just had a phone consultation from her country it was just a virtual consultation to a doctor, but she did not go to a doctor here. Patient stated she decided to get it to be protected since she has never been infected with COVID and when it was available, she got it to feel safe. The outcome of events was left side facial paralysis and her tongue was still numb, cannot blink her left eye was not recovered, numbness on the left side part of her face was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Member presented with local rash that started w/in a few hours of vaccination. By the following day there was a migratory rash, erythematous and slightly raised, pruritic in nature on bilateral arms. Started on dorsum of hands and wrists and moved up arms. No throat swelling or difficulty breathing. Member was prescribed Atarax which improved symptoms. When she woke the following day the rash was nearly resolved. No distracting itching present.
it's still kind a sore; Arms swelled up on my left side, under my armpit; maybe it's lymph node or something but it swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for Covid-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), outcome "unknown", described as "it's still kind a sore"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Arms swelled up on my left side, under my armpit; maybe it's lymph node or something but it swelled up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, body aches, fever, ear pain. Loss of feeling/sensation in right thumb.
Pt recvd 3 doses of Heptavax in 1985 & had pos antibody titers until 1991; recvd 2 booster doses of Engerix-B on 6SEP91 & 27NOV91 titers remained neg following booster injects;
Light headed when walking around/ Patient started experiencing dizziness 2 days after getting 1st dose; Soreness in the arm; Light headache 2 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed when walking around/ Patient started experiencing dizziness 2 days after getting 1st dose), PAIN IN EXTREMITY (Soreness in the arm) and HEADACHE (Light headache 2 days after first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Light headed when walking around/ Patient started experiencing dizziness 2 days after getting 1st dose), PAIN IN EXTREMITY (Soreness in the arm) and HEADACHE (Light headache 2 days after first dose). At the time of the report, DIZZINESS (Light headed when walking around/ Patient started experiencing dizziness 2 days after getting 1st dose), PAIN IN EXTREMITY (Soreness in the arm) and HEADACHE (Light headache 2 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication taken by patient was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Follow-up attached. Added concomitant medication Updated suspect drug information. Added new events
6" hard nodule right thigh. Hot to touch. Red and swollen. Dr. told to use warm compress.
One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 27Jan2021 at 12:00 (at the age of 45-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history multiple sclerosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received codeine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03Feb2021 at 12:45, the patient experienced one week after the first shot, his legs went weak and gave out while she was walking at work and she fell and got a concussion because she hit her head. Patient stated that 3-4 weeks after the second shot, I had the first major MS exacerbation I have had in 15 years. It was the worst I have ever had. My legs went weak when I stood up at home and my teenage son caught me so I would not fall and hit my head again. He took me to the ER 2 days later because I knew something else did not feel right. The neurologist on staff at the hospital made me get a 2 hour MRI and it showed so many lesions that it is sad. I only had 2 lesions 15 years ago. This was horrible. Patient visited doctor or other healthcare professional office/clinic visit due to events. The patient underwent lab tests and procedures which included blood test and Covid test was negative on 02Apr2021. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
swelling, hardness at injections site, redness extending along 2/3 of upper arm that lasted for 5 days
angioedema; welts/hives; random swelling over different areas; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation. Concomitant medication included adalimumab (HUMIRA) taken for immune suppressed, start and stop date were not reported. The patient reported that since receiving the second dose of the vaccine, he/she developed angioedema on an unspecified date and believed to be caused by the vaccine. Patient also had welts/hives and random swelling over different areas on an unspecified date. The symptoms were somewhat under control with a Claritin once a day. Patient was on Humira therefore immune suppressed. Although patient take steroids when having flare, he/she takes steroids and rest. Patient was prescribed Epi pens as well as a precaution. Outcome of the events was unknown.
patient received the first dose of Shingrix a year ago and has not received the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as an adult as per vaccine indication. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Area of erythema  on right arm at vaccine administration site, 3 inches long and 1.5 inches wide.  Still present as of this reporting.  Site is slightly warm to the touch and slightly tender on palpation.  Minimal pain when using right arm.  No blisters, bumps, or rashes noted elsewhere on body.  Temperature got as high as 100.4  during the 24-48 hour period following the injection.
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 23-MAY-2014, the patients were vaccinated with ROTATEQ INJ, lot J015062, expiration date 13-OCT-2015 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004963, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1409USA004900, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
ADMINISTRATION ERROR:  Vaccine was drawn up, verified by nursing staff and was given to the child, which was the incorrect vaccine.  He did not have any prior COVID dosing, and should have received the Monovalent vaccine not the bivalent.  He did not have any reaction to the vaccine.  He was monitored for just over 15 minutes.  He did receive the flu shot at the same time on the opposite leg.
WEAKNESS, URINARY INCONTINENCE, HEADACHE, Passed out for 6 hours as pt fell out of bed after attempting to roll out of bed Narrative:  82 y/o male who lives by himself received his Moderna vaccine on 1/26/21 around 12:38pm. Pt stated it took him ~1 hr to drive back home from facility to his house on 1/26/21. Pt stated during the drive he was "shaking". He went home and went directly to bed. He said that night he woke up, but could not sit up. He rolled out of bed and fell on the floor as he attempted to go to the bathroom. Patient reported that he "passed out" for ~ 6 hours, but informed this writer he did not hit his head. Pt had + incontinence. Pt could not get off the floor and slept there until 2/27/21 afternoon. That is when patient called the agency Contact Center. Pt stated he did not call 911 at the time. He reported being "very tired, weak and shaky" for 3-5 days.