chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient reported to pharmacy on 10/20/22 that he had moderate lymph gland swelling under his left arm (where he had gotten flu and covid shot in the same arm the day before).  The swelling started 10/20 and was increasing, not limiting movement, no hard module, just "feels full" and "tender".  He reported fever started in the night 10/19 and continued into 10/20 am. Pt also reports left arm is increasingly sore, mildly on 10/19, and increasing throughout the day on 10/20. shoulder motion ok.
Red, tender, warmth to (L) leg at injection site. C/O pain to touch. Denies fever.
Sore at spot of injection; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 04Mar2021, at 18:00 the patient experienced sore at spot of injection and also reported that aspirin did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore at spot of injection and included treatment with aspirin. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore at spot of injection was not recovered at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of joint swelling in a female subject of unspecified age who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 27 November 2013 the subject received a dose of FLUARIX quadrivalent (unknown). On an unspecified date, within months of vaccination with FLUARIX quadrivalent, the subject experienced swelling to her joints. No other information was provided. At the time of reporting the outcome of the joint swelling was unspecified. Follow-up information received on 19 February 2014 via pharmacy who reported the subject was an adult in his 40's. The outcome of the joint swelling was unknown. No other information was provided.
Feeling tight in the throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Feeling tight in the throat) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H214) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First two shots were Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Shellfish allergy (Patient mentioned whenever she had contact with shellfish, her hand would blow up.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced THROAT TIGHTNESS (Feeling tight in the throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat tightness, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Feeling tight in the throat) was resolving.            Patient was not pregnant. Patient asked whether shellfish or shellfish-derivatives ingredients in the Moderna booster were there shot. She said she read the ingredients but was not sure. Patient was not sure if throat was feeling tight was related to the vaccine. Apart from that patient had no other symptoms. Symptoms started around 2 hours after the shot, it was subtle at first, but started feeling tight in the throat so patient looked up the ingredient list. She's feeling better after taking one Benadryl. Patient has not seen a doctor about it.
HOT, RED, SWOLLEN ARM 1 INCH BELOW INJECTION SITE, TEXTURE OF AN ORANGE WITH BURNING SENSATION. SHOULDER TO NECK IS SWOLLEN, RED, AND HOT.
Hyperthyroidism or some sort of autoimmune disorder. No one in our family on any side, has hyperthyroidism. We are trying to figure it out. It mimics hyperthyroidism. Has the same symptoms as Grave but Graves? disease was negative. Dr. said ?she?s not textbook?. He?s been doing this for about 30 years. Started losing massive amount of hair within a couple weeks of second dose. She  has less than a third of the hair she had before the vaccine and is losing more daily.  When put on methimazole for treatment, she reacts with extremely painful, deep mouth sores. Which isn?t typical. She?s never had mouth sores before.  I?m wondering if it?s related to the vaccine. Her thyroid numbers were ? a little high but not bad? before the vaccine. But I?m wondering if the vaccine has something to do with it.
Pain in joints in left wrist, as of 08/20/2021 severe pain at base joint of left pointer finger.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.50 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
ulcers on top of and under her tongue.; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ULCER (ulcers on top of and under her tongue.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ULCER (ulcers on top of and under her tongue.). At the time of the report, ULCER (ulcers on top of and under her tongue.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the vaccination about 48 hours ago and has developed ulcers on top of and under her tongue.
Patient received their covid 19 vaccine around 8:30 pm and when to go sit in the waiting area. after a few minutes he called out for help because his vision was going black. I immediately rushed to his aid. PT stated  they felt like they were going to pass out. I provided the patient with water and a granola bar because he said he did not eat since 12 pm that day. Pt began to feel better after the water and snack.
pt recv vax 17OCT96 & 25OCT96 pt exp a fever of 102 to 104.5;9OCT96 pt was seen y MD;the same day pt urine cult was negative;29OCT96 blood work was done revealing WBC count 14,000 w/68 neutrophils, 28 lymphocytes, 9 monocytes;
Back Pain, Fever, chills x 2 days. Fever was 101.4
Pt recv vax & exp fever & ache in her back.Also devel rash on trunk which went away w/in a few hr.Backache persisted at time of report.
This spontaneous report as received from a consumer regarding her sister in law who was an 80 year old patient. Approximately on an unknown date in 2008 (reported as 5 years back) the patient was vaccinated with a dose of ZOSTAVAX (Lot number expiry date, route and dose were not reported). Approximately on an unknown date in April 2013 (reported as last week), the patient broke out in shingles on her back. The reporter wanted to know if a booster was needed since she and her husband were also vaccinated around the same time. The outcome of broke out in shingles on her back was unknown. Additional information is not expected.
started on the 8th day my arm started itching i saw that it was swollen about 3 inches around and it was red and very warm to the touch and had red bumps on it,  took about 3 days to recover
I did experience the common side effects that are listed, fever, chills, headache, pain to site of injection, fatigue, and terrible headaches. The issue that I am concerned about at this time is I am experiencing still pain to my left arm and shoulder area that is like a constant burning pain that radiates to the top of my chest.  .  It is a constant irritation feeling that has not resolved since my 2nd shot.  My chest feels the same way and feels like a kind of heavy sensation to it.  I still do experience headache and fatigue that is not normal to me.   When I exercise I experience some shortness of breathe  that is not my normal upon exertion.  I did have Covid July 4, 2020.  I did experience headaches, body aches, chills, however I never ran a fever or nor did I have a cough.  I had pretty mild symptoms.  I feel my symptoms completed resolved.  When I had the 2nd vaccination I felt worse than when I actually had Covid.  My major concern is the pain in my left shoulder and the shortness of breathe that I have.  I feel that it has been an issue that developed when I was vaccinated.  I had a CXR in September due to a surgery I had to have, at that time there are no documented issues of my chest at that time.
at approx 3:15 (10 min after injection)  pt c/o feeling clammy, diaphoretic.   B/P taken--157/115.  IV started and Pepcid 20mg and Benadryl 25mg given IVP.    pt still hypertensive and was sent to ER for eval.   In ER pt reports she was monitored for approx 2 more hours.   She had EKG which was reported by pt WNL and CXR which was WNL.  lab work--reported sodium low and KCL low.  Given oral K before leaving ER.   B/P before leaving was still 148/98.    Today 1/11 pt reports B/P 140/94.
devel gen urticaria w/in minutes;no wheeze or dyspnea;DPH given;pt released p/observation for 45min;
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Number of doses administered was 173 doses. The vial did not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Immediately following the vaccine administration pt started to c/o dizziness, chest pain and pressure, SOB. VSS  at 122/58, 103, 22, 98%.
Patient report that at midnight after the vaccine she started having Fast heartbeat & body vibrations , also she had soreness on the back of her neck and fever and sore arm...
A non-serious, spontaneous report of patient received half dose of FLUMIST was received from a health professional concerning a 15-years-old patient. When administering FLUMIST, the nurse did not remove the clip from the syringe in order to provide the second dose. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments were not applicable, and the event was considered resolved.
Has been sick ever since; joint pain; Fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Has been sick ever since), ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 029M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (Has been sick ever since). 30-Mar-2021, the patient experienced ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Has been sick ever since), ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
90 y.o. Nursing home resident with comorbidities including  oxygen dependent CHF with gradual declining course prior to 1st dose of COVID 19 Moderna vaccine died 12 days after receiving 2nd dose. Resident experienced increased dyspnea and hypoxia 5 days after receiving 2nd dose.
After receiving the GARDASIL vaccine child passed out for a few seconds then recovered and examined by physician.
Per pt, the evening of vaccine administration, he developed the expected soreness in left arm where vaccine was administered, but also unexpectedly developed pain and spasm down the left side of his back, from the shoulder down.  Over a few days the pain in the arm subsided, but he continued to complain of pain in back.  10 days later he again called to report that pain in back and (also arms?, message was not clear) persisted and patient felt was definitely related to the vaccine.   He had been advised to see his MD on 10/27/14 (5 days post vaccine) for an evaluation, when it became clear the symptoms were persisting, but he has yet to do so as of 11/4/14.
nauseous; Random pains in right arm too (not injection site arm); injection site redness; body aches; arm was super itchy; thrush; mouth felt funny; Canker sores; pain in cheeks; pain in legs; swollen arm; arm was super sore; felt fluish; Feeling off; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks) and PAIN IN EXTREMITY (pain in legs) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off) and HEADACHE (headache). On 06-Jan-2021, the patient experienced CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), PRURITUS (arm was super itchy), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)). On 08-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off), PRURITUS (arm was super itchy), PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)), HEADACHE (headache), NAUSEA (nauseous), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches) outcome was unknown. ER visit 07-Jan-2021 details 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt started to have epigastric pain three days after 1st and second doses of Moderna CV 19 vaccine.
Initial report received from a HCP on 23 Feb 2010. This patient (a child of 3 years old) was inadvertently received a 0.5 mL IM dose of S-OIV FOCETRIA (batch no: 102041P1) on 23 Feb 2010. No adverse effects were reported after administration.
Round red painful area at injection site (1.5 inches in diameter). Headache today.
On 1/8/2021 I woke up with severe chest pain under my breast bone, radiating to my upper back. It came in waves a severe sharp pain and then was dull. I?ve never had heartburn or indigestion so I went to Urgent care around 10am on 1/8/2021.
Shots this morning around 11 AM  Fussiness and not eating since shots.  Tylenol at 12:45 and again in office at 4 PM.  Cool compresses applied to both legs.  Right and left thighs red.