chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have seasonal allergies so it felt like a really bad allergy day with an extra sore throat. I completed a COVID at home test and was positive. I rested and took a lot of Tylenol. I drank a lot of fluids. I spoke to my doctor who prescribed Paxlovid for me. I completely recovered in about 8 days. I did not get super sick but I was sick for quite a while.
Patient had issues with the first shot. Feeling at present a "little queasy." Felt better lying after injection .R/T didn't want to have signs and symptoms again.
WITHIN 15 MINUTES OF COVID VACCINE GIVEN PATIENT WAS COMPLAINING OF ITCHING
A non-serious spontaneous report of got full dose of FluMist in one nostril was received from a registered nurse concerning a 43-month-old male. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing concomitant on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
I contracted COVID-19 on 05/19/2022 with symptoms of fatigue, then further symptoms of fever of 100.9, cough, runny nose, headache, myalgia, congestion, and shortness of breath developed the following day. I went to the ER on 05/21/2022 because my O2 saturation levels dropped down to 92, and my creatinine was elevated, I was given fluids, and my O2 levels came back up and I was released. My symptoms are resolving as of today 05/24/2022.
Redness initiating at site of injection and radiating to front of left arm with 2 red streaks and 2 whelps.
Fever and chills lasted about 4 hours.  Body aches and tiredness lasted about 24 hours.  Heart was racing very fast during the feverish period.  Elevated heart rate for 2 weeks following shot, but I subsequently realized that I had become much more sensitive to caffeine; when I cut down my coffee consumption by half, the heart symptoms went away.  At a doctors visit on 12/14 my EKG and bloodwork were normal.
pt states that a couple of weeks after taking the vax she ended up in the Hospital ER on 3/18/2021 for symptoms of having a stroke and blurred vision.  On 3/18/2021 Pt was transferred to Hospital in.  They ran ECHO, EKG, CT and MRI.  Blood Work.  No findings of clogged arteries.  DX was w/ TIA possible cause due to AFIB.   Pt states that she no longer has any symptoms.
So the evening before, my friends and I had a gathering, the next AM, I was having a lot cramping right lower quadrant, and feel my abdomen pressing on it worse. I was hoping it would go away. I was feeling nausea, I laid in bad and didn't go to work that day. I didn't get better after a few days. Normal bowel movements. I thought I among have an appendicitis.
After the 1st dose of the vaccine, about 1 week later I had a mammogram.  The doctor called a few days later to inform that I had a swollen lymph node in the right axillary (arm pit) and they wanted me to do an ultrasound.  I went ahead to get the ultrasound and the results of the ultrasound  did confirm the swollen lymph nodes and the radiologist says that the structure of the lymph nodes were normal and there is no concern.   I went ahead and proceeded to get the 2nd dose vaccine on 2/3/2021 (lot 031L20A IMRA).  I had no adverse reactions or events after the 2nd dose that I can feel or see).  I am to wait 12 weeks to get a 2nd ultrasound.  I did get the 2nd ultrasound which came back normal and there were no swollen lymph nodes.
Child tolerated administration of vaccines well. Child left office with family after appointment. Our office was notified the following day (5/22/2019) that child died overnight. She was found unresponsive. She was taken to an Emergency Department. Resuscitation was attempted.
This spontaneous report was received from a pharmacist referring to an approximately 62 year old female. The patient had no pertinent medical history or current conditions. The patient's known allergies included cephalosporin and macrolide allergy.  On 19-NOV-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. In September 2016, the patient developed a case of shingles. The pharmacist reported, she felt the shingles may had been caused by stress, as the patient's husband had recently died. The patient sought for medical attention, however it was unknown if treatment was provided for the adverse event. No  product quality issue was involved. At the time of the report, the outcome of herpes zoster was reported as recovered in 2016. Additionally, the reporter did not provide for a causality between the adverse event and vaccination with ZOSTAVAX. Additional information has been requested.
On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (General discomfort), PAIN (pain in the site), NAUSEA (not sick, don't feel nauseated), ILLNESS (just don't feel well.) and ARTHRALGIA (sore shoulder). At the time of the report, DISCOMFORT (General discomfort), PAIN (pain in the site), NAUSEA (not sick, don't feel nauseated), ILLNESS (just don't feel well.) and ARTHRALGIA (sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves eight-years old female patient who experienced significant arm swelling and redness of the injected arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route. On an unknown date, the patient developed a non-serious significant arm swelling and redness of the injected arm, six-days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was significant arm swelling and redness of the injected arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for significant arm swelling and redness of the injected arm.
Evening of imm. (07/23)developed redness, soreness and swelling right arm from elbow to shoulder.  Worsened the next day (07/24) and also c/o feeling tired and nauseated.  Temp.  not checked but "felt warm." By 07/26, arm was still red but improving.  On 07/27 no more c/o nausea or feeling tired, arm no longer red, still a little swelling.  Analgesics helped with discomfort, but not with swelling or redness.  On 07/29, client's arm still a little swollen but going down, no redness.  Swelling gone by 08/01 or 08/02.Instructed to call HD if any more problems.
Patient reported local irritation, swelling and redness and slight fever. Patient reports exceptional tiredness and runny nose. Local reaction continued to worsen with increased soreness and development of knot at site and weakness in the arm.  Reported slight numbness around mouth and lips that increased and was spreading to face.  Reported that she routinely take NSAID.
Shingles on head- 5 days subsequent to the second dose of Moderna Vaccine
Patient experienced redness down his right arm the following day. Later he developed a rash on his lower right leg and swelling of the lips. He was seen by physicians and received hydroxyzine and prednisone.
Crying/irritable - to ER. GI - mild distension, soft, nontender, no masses. KUB showed - "doesn't appear like intussusception; looks like she gave herself an air enema".  10/15/2007 VAX record received and info updated in database./pc  11/05/2007 ER record received for DOS 9/4-5/2007. Child presented to ER with parental report of inconsolable crying and not wanting to eat.  Mom reports abdomen appears swollen and child appears pale. PE WNL. D/C home with DX: Crying. 11/06/2007 Spoke with reporter.  Pt did not have DX of Intussusception.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient age was reported as 60.29. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 9:00 AM . This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
stomach cramps started 26JUN96 @ 2AM;t101 next morning 26JUN96 & dec appetite, nausea, no vomiting;27JUN96 stomach cramps lessening;dec temp, starting to eat food;no other sx reported;
body aches; This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), Solution for injection, via an unspecified route of administration, administered in Arm Right on Patient's Medical History (including any illness at time of vaccination) was reported as none. Concomitant medications were not reported. Family Medical History Relevant to adverse event was reported as none. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 10Feb2021 at 06:00 AM, the patient experienced body aches. He stated that the body aches started the morning after the shot at about 6am. He did play golf yesterday and was achy, and today he has no side effects. Patient did not have other relevant diagnostic and confirmatory test results for event. Patient did not visit emergency room or physician's office due to adverse event. The event was recovered on 11Feb2021.   Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2022) Negative; (26Oct2022) Negative; (29Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 19Oct2022 to 23Oct2022.  No follow-up attempts are possible. No further information is expected.
injection site (left arm) soreness; This symptom is a daily occurrence and gets worse when patient is at rest.; anxiety; Fasciculation; muscle twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Oct2021 09:15 (Lot number: EW0186) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: SETLAKIN taken for contraception. Past drug history included: Amoxicillin, reaction(s): "Rash"; Compazine, reaction(s): "dystonic"; Ambien, reaction(s): "paresthesia". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 13Oct2021, outcome "not recovered", described as "muscle twitching"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site (left arm) soreness"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "This symptom is a daily occurrence and gets worse when patient is at rest."; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Fasciculation". Therapeutic measures were taken as a result of anxiety.  Additional information: On 13Oct2021, she started to have muscle twitching (Fasciculation) in her left tricep. This happens randomly throughout the day especially at rest. This has been happening every day since with the severity varying from a few minutes once or twice during the day to frequently during the day causing issues especially at night with sleep. Patient have not seen a physician yet because she was hoping this may not be related to the vaccine but rather anxiety related to receiving the vaccine and a very busy work schedule onto of other things. In an attempt to try to remedy this, she had tried to increase my water intake along with magnesium and calcium levels. So far nothing has completely resolved the issue although she do find that by targeting that muscle group through weight lifting will alleviate the symptoms for a longer period of time. Prior vaccinations (within 4 weeks): None  No follow-up attempts are possible. No further information is expected.
RESIDENT PASSED AWAY ON 12/29/21 ON HOSPICE SERVICES WITH COMFORT MEASURES IN PLACE
This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L043634/ expiration date- 03-NOV-2017. No concomitant medication was reported. On an unknown date patient experienced swelling and redness. The outcome of the swelling and redness was unknown. Causality was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
SORENESS/BODY PAIN; HARD TO CONCENTRATE; FEVER 101.5; DIZZINESS; TROUBLE BREATHING; CHEST TIGHTNESS; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 19 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced soreness/body pain. On 08-APR-2021, the subject experienced hard to concentrate. On 08-APR-2021, the subject experienced fever 101.5. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced trouble breathing. On 08-APR-2021, the subject experienced chest tightness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness/body pain, hard to concentrate, fever 101.5, dizziness, trouble breathing, chills, tired, and headache on APR-2021, and had not recovered from chest tightness. This report was non-serious.
At first, discomfort to the muscle area of the right shoulder area. As time went on, the pain in this area became more severe and was reported to my PC at the Facility 1.5 years ago. Sonce that time, the pain has become so severe that at times ona scale of 1-10, it was an absolute 10, unable to move the left arm without assistance or holding an item without shaking or dropping. Each time I had reported the discomfort with my PC each additional appointment, now totaling 3 times. There's no topical sensitivity except from the injection site from 2/26/21, and if pushed inward, discomfort can be felt. Radiology was ordered whereas no abnormality was found to the bone structure. Physical Therapy was also ordered.
Began as Dizziness on 3/31, then double vision, vertigo. Adm to The Hospital on 4/1. Diagnosed with TIA. Home next day. Now on hear monitor.
pt recv vax 25APR95 & was found to have elevated CPK level;pt has been referred to a neurologist
My only symptom was the result of taking my blood pressure. I had no outside symptoms that would have let me know I was having high blood pressure. Since it was over 200/100, I went to the hospital. It got as high as 248/126. They gave me IV medication and kept me until they got it lowered. It took about five hours. They also told me to follow up with my doctor.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-JUN-2016 the patient was vaccinated with GARDASIL lot # K023432 expiration date 18-JUN-2016, intramuscular. Dose and frequency were not reported. No other suspect or concomitant therapy was reported. No adverse events were reported. Additional information has been requested.
Pt said his arm "itched" for 11 months, but never had reaction before.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient (Age: 65, Units: Unknown) of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included influenza vaccine administered on the same day in the same arm for immunization. The patient experienced arm stiffness on an unspecified date after use of the product. The outcome of the event was unknown.