chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild headache, started 10 min. after vaccination. Has not eaten or drank anything today. Given water-Seen by Medics.  No further interventions. Left in stable condition at 10:34 a.m. Recorded by RN.  Medic
covid vaccine breakthrough case  dose 1 Pfizer 1/21/21 EL3249 dose 2 Pfizer 2/11/21 EM9810 dose 3 Moderna 11/26/21 071F
administered the Fluzone High Dose last night and it leaked around the hub of the syringe, no adverse event; administered the Fluzone High Dose last night and it leaked around the hub of the syringe, the patient did get some dose but not all, no adverse event; Initial and follow-up information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 74 years old male patient who was administered the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], prefilled syringe last night and it leaked around the hub of the syringe, (lot number: UJ213A, exp date: 26-Mar-2020 in arm NOS via unknown route on 26-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation.  It was a case of actual medication error due to vaccine underdose (underdose).  This was also a case of device issue (syringe leak).  Case details: Nurse states she administered the Fluzone High Dose last night to a male patient and the vaccine leaked around the hub of the syringe. The patient only got about ¼ to a ½ of the dose. The patient was not of good health.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
My left ear went deaf and I went to a walk in and told me to take antihistamines. I waited 5 days and made an appt to see an ENT doctor. I went Tuesday morning and he said there was no fluid in my ear, it was nerve damage, SSHL hearing loss and they did a bunch of audiologist tests. He is proceeded to give me shots in my ears and giving me steroids to see if I can get my hearing back.
This spontaneous report as received from a registered nurse refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# FC3183), in left arm, on Sep 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a vaccination site rash (large red rash on left arm), rash, onset Sep 2021, with outcome of unknown; fatigue (experienced little more tiredness than normal) and paresthesia (tingling in left hand), onset Sep 24, 2021, with outcome of unknown. Additional information: Patient stated, "I have a large red rash on my left arm where I received a shot on the left-side of my arm. I experienced little more tiredness than normal. I have tingling in my left hand, where  the Pfizer shot was given. I just wanted report what I have going on. I have this rash. I never had anything like this before." Follow-up attempts completed. No further information expected.
Eight days after receiving my first Moderna vaccine, my right arm developed a red, circular rash. It is slightly warm to the touch, sore but not painful, red and itchy.  As of today, the redness has slightly faded and the other symptoms are improving..
Fever, HA, neck pain, body aches. Fever broke Tuesday 9/4/12. Rash started on chest & back Wed. night 9/5/12. Glands are also swollen.
Patient presented for 1st Dose of Moderna vaccine. Patient stated that primary PCP recommends vaccine. Pt reported reaction to flu vaccine 10years ago, Pt developed pneumonia.   Pt also reported reaction to allergy shots, that she was receiving for environmental allergies. States was given a high dose and had anaphylactic reaction. this was 3 years ago.   Vaccine administered to patient, after 5 minutes Pt c/o shortness of breath and tingling sensation to hands. Primary Care practice MDs supervising vaccine clinic immediately called to room, rapid response initiated.  pt's vitals were taken. 122/80, 107, 98.4, 75% 02. pt given oxygen via NC at 2liters. Epi pen administered to pt by Primary Care office provider to left thigh. pt was extremely anxious. Pts husband called. Pt transported to ER via W/C.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt experienced a severe headache, spinal pain, nausea, vomiting, fever over 6 hours. Treated with Demerol, IV-Reglan
This spontaneous report as received from a physician refers to a 70 year old female patient. The patient received ZOSTAVAX (lot# unspecified) on an unspecified date in September 2010 and developed a mild case of the shingles on her torso on an unspecified date in April 2013. The outcome of a mild case of the shingles on the torso was reported as recovering. The patient had sought medical attention via office visit. Additional information has been requested.
Swelling at injection site, fever, chills, nausea, headache, muscle weakness and joint pain.
Racing heart rate >100 woke him up out of a sound sleep around 10pm on day of vaccine. (Vaccine was given approx 1:40pm) lasted about 30 minutes then it calmed down to more normal heart rate. Next morning bad headache 5-10am. Took Tylenol for it. Also, pain at injection site, across shoulder and lower neck for approx 24 hours after shot.
migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "migraine". Therapeutic measures were taken as a result of migraine.  Additional information included: It was on and-off for 3 weeks and only subsided completely with a Medrol dose pack prescribed by her neurologist.   No follow-up attempts are possible. No further information is expected.
she got the first dose of the covid vaccine on 04Jan, scheduled to get the second dose of the covid vaccine on 24Jan; experiencing runny nose; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age was scheduled to get the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 11:28 at single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, ongoing torn rotator cuffs. The patient also believed she was immunocompromised. The patient confirmed that the shoulder pain that she was getting the Cortisone shot for was prior to the COVID shot and she had been getting them for some time. The patient previously took prednisone regularly and took BNT162b2 (Batch/lot number: EL0142, Expiry Date: 20Mar2021) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization and had swelling and pain on the arm that was injected on an unspecified date in Jan2021. Also, she had a fever and felt lethargic that night but the next day she felt fine. The caller clarified that the next day she actually could hardly get out of bed and felt fatigued and tired. Her temperature reached 100.7. This happened on 05Jan2021. The patient's concomitant medication was not reported. Caller asking if she can have the second dose of the covid vaccine if she was scheduled for a cortisone injection to both of her shoulders. Caller reported that she got the first dose of the covid vaccine on 04Jan, she was now scheduled to have cortisone injections to both of her shoulders for torn rotator cuffs on 13Jan and then scheduled to get the second dose of the covid vaccine on 24Jan. The patient got the second dose of the vaccine on 25Jan2021 11:28 and is experiencing runny nose and colds. The outcome of the events was unknown.   Follow-up (25Jan2021): New information received from a contactable consumer includes: additional events (runny nose, and colds).   Information on the batch/lot number has been requested.
Extreme fatigue. Feel better when lying down. Can only be upright and active for about an hour or so before needing to lie down again.
I was sicker than a dog; Initial information regarding an unsolicited valid non-serious social media case received from consumer or non-healthcare professional on 30-Nov-2020.  This case involved patient (with unknown demographics) who was sicker than a dog (illness) when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (reported: two days later) the patient was sicker than a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
sweating after one of her Moderna Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating after one of her Moderna Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating after one of her Moderna Covid-19 vaccines). At the time of the report, HYPERHIDROSIS (sweating after one of her Moderna Covid-19 vaccines) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Blood clot; Couldn't breathe; Heart palpitations; Hives; vertigo; This spontaneous case was reported by a health care professional and describes the occurrence of THROMBOSIS (Blood clot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical History not reported.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo). At the time of the report, THROMBOSIS (Blood clot), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo) outcome was unknown. Not Provided      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.   On 15 Mar 2021, within 1 hour of receiving first dose of the Moderna COVID-19 vaccine, the patient couldn't breathe, she had heart palpitations, hives, vertigo, and a blood clot. The patient stated that she was able to fell the blood clot.  At the time of the report it was unclear if the patient had seen a physician for the events.  Treatment for the event was cetirizine, and the patient stated that she has no hives when she takes cetirizine, but once  she stops the cetirizine the hives return.  Treatment provided with cetirizine for hives.
COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No allergic condition reported by the reporter.  Previously administered products included for COVID-19: PAXLOVID from 06-May-2022 to 10-May-2022. Past adverse reactions to the above products included No adverse event with PAXLOVID. Concurrent medical conditions included Hypercholesterolemia.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.). At the time of the report, COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.) outcome was unknown. Not provided.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) positive test with new symptoms. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative test after treatment.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. Company comment: This spontaneous case concerns an 81-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 198 days after administration of third dose of mRNA-1273, the initial two doses were given approximately 8 months prior, the interval between the two doses is 28 days. On May 22, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an 81-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 198 days after administration of third dose of mRNA-1273, the initial two doses were given approximately 8 months prior, the interval between the two doses is 28 days. On May 22, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The day after her second dose, the patient experienced a rash on her back, chest, and stomach. It resolved after 4 days.
Increased irritability with green/mucus colored stool with presence of blood, which was Hemacult + and in office, pt improving.
30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized, outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy) WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending) COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).
No improvement/gotten worst with humira; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (No improvement/gotten worst with humira) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (No improvement/gotten worst with humira). At the time of the report, CONDITION AGGRAVATED (No improvement/gotten worst with humira) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On an unknown date, the patient experienced no improvement/gotten worst with Humira. No treatment medication reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No additional AE; Medical assistant reported a dose of MMRII with a labeled expiry of 5/11/2022 was administered to a patient on 5/17/2022. Caller reports no temperature excursion involved. No additional information was provided. No additional AE/PQC was reported.; This spontaneous report was received from a medical assistant, concerning a 12-month-old patient of unknow gender. The patient's historical conditions, concurrent conditions and concomitant therapies were not reported.   On 17-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA)  (M-M-R II) 0.5 milliliter, product quantity 1, lot #T016198 with expiration date: 11-MAY-2022 (strength, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). No additional adverse event was reported.
No adverse effects reported; Wrong vaccine administered; This spontaneous report was received from a medical assistant via a company representative referring to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 06-SEP-2016, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) reconstituted with a correct storage sterile diluent; instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, anatomical location, route of administration were not reported) lot# L043704 with expiration date on 04-NOV-2017 for prophylaxis (wrong product administered).   The reporter stated that the lot# for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was actually found to be the lot# for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). In addition, this was considered a medication error by another medical assistant.   No adverse effects were reported.
Palpitations/PACs/PVCs started about an hour to hour and a half after administration.
NO RAYNAUD'S SYMPTOMS IN HANDS SINCE VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced no raynaud's symptoms in hands since vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no raynaud's symptoms in hands since vaccination was not reported. This report was non-serious.
I had persistent cough, slight fever, lots of congestion, extreme tiredness. I went to the ER and they tested me for COVID-19 and I was positive. They gave me azithromycin and a steroid.
No adverse outcome noted. Found error on data entry of vaccine into system. Pt received adult dose of vaccine rather than pediatric dose.
3 min febrile convulsion in assoc./w fever to 105 F within 12 hrs of receving DTP.  Was evaluated @ Hospital ER- full septic W/U; neg C.P.(/), all results neg. observed overnight- no sequele
Pt. reported to pharmacy on 11/11/20 11/7/20 pt. reported waking up with swollen underarms (mom believes lymph nodes) after receiving flu vaccine one 11/6/20. 11/11/20 mom reports to pharmacy pt. still has swollen underarms and pain radiating to elbow 11/18/20 pharmacy followed up with pt. mom states pt. saw doctor on 11/12/20. Dr. determined cause of reaction may be due vaccine. Pt. was advised by doctor to taken Ibuprofen and ice area. Continue to monitor if continues, Pt. may need to be seen for steroid shot. -no fever reported.
Approximately 5 hours after the injection I started having full body shaking with got progressively worse.  I vomited up my dinner twice. I was running a fever of 101.  My wife and I went to the emergency room where I was tested for COVID19. Blood was drawn, urine samples taken. I soon felt better and was sent home the Dr. rulled out food poisoning and said she didn't know what the cause was. We determined by a process of elimination the it was the flu shot.
pt recvd vax; had recurrent bacterial infect; mom feels that pt's immune system has been damaged;