chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 2:02 PM, 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.   The age of patient was provided as 39.90 years.  Concomitant products were not provided.  On 09-Feb-2021, vaccines with batch number 031L20A were moved to the fridge. On 17-Feb-2021, three vials were moved to clinic. On the same day at 08 AM, vials underwent temperature excursion with temperature 20 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 10-Mar-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 traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
AFTER BEING VACCINATED WITH FLUMIST, PATIENT GOT SICK WITH THE FLU.; PATIENT WAS VACCINATED USING FLUMIST FOR TWO YEARS IN A ROW, IN THE THIRD YEAR HE WAS NOT OFFERED FLUMIST FROM HIS HCP AGAIN BECAUSE HIS HCP SAID FLUMIST DID NOT HAVE A HIGH ENOUGH LEFT OF EFFICACY TO CONTINUE USAGE.; A spontaneous report has been received from a consumer. The report concerns a male patient of ethnic origin (age 19 years).    No medical history was reported.  The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date. The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date.     A Unknown administered FLUMIST. No malfunction has been reported for this combination product.   A Unknown administered FLUMIST. No malfunction has been reported for this combination product.    The report described lack of effect for Flumist and Flumist. The reported term was "patient was vaccinated using flumist for two years in a row, in the third year he was not offered flumist from his hcp again because his hcp said flumist did not have a high enough left of efficacy to continue usage." (Preferred term: Drug ineffective).     On an unknown date, the patient experienced after being vaccinated with flumist, patient got sick with the flu. (preferred term: Influenza).     Treatment with Flumist (influenza vaccine live reassort 3v) and Flumist (influenza vaccine live reassort 3v) was discontinued.     The patient recovered from the event(s) of patient was vaccinated using flumist for two years in a row, in the third year he was not offered flumist from his hcp again because his hcp said flumist did not have a high enough left of efficacy to continue usage. and after being vaccinated with flumist, patient got sick with the flu. on an unspecified date.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction 07-Nov-2023: Association updated. Narrative updated.
Started with the worst body aches imaginable along with chills so bad I had to curl up with a heating pad under the covers just to stop shaking. This went on all night. I also experienced nausea and heart fluttering during this time. The whole day after that I was so weak and tired I could hardly hold my head up. I noticed at this time that my tongue had some strange discoloration and my face felt numb in some places. Today, I am feeling better, however I am still exhausted and my tongue is still discolored and my face is still numb, especially around my mouth.
Left thigh cellulitis. Treated with Omnicef 120/5/ml 3.5 ml twice daily for 7 days.
Information has been received from a nurse referring to a patient of unknown age and gender. On 27-JUN-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K008822, expiry date: 19-JUN-2016). Additional information has been requested.
I began to develop a large welt at the site of injection shortly after the Pneumovax. Then, later that evening, I had a headache, myalgias and fatigue. I awoke the following morning with shaking chills and a fever. This evolved into a high fever of nearly 107 untouched by antipyretics, and requiring an ER visit. The local reaction also progressed, and developed into a cellulitis over nearly my entire arm. I continued to have high fevers in the 103-106 range for three days following despite dual antibiotic use, and was nearly hospitalized by my physician. Fever, headache, myalgias, shaking chills, and severe pain in the arm with the local reaction all lasted for several days.
started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with the sweats; he started to get hot with the sweats; terrible headache; dizziness; nauseated; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 00:30 (lot number: ENG6199) (at age 55 years old) as single dose for covid-19 immunization administered in a pharmacy or drug store. The patient had no relevant medical history. No known allergies. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medication included tramadol taken for numbing shot for tooth, start and stop date were not reported. No other vaccines received in four weeks. The patient experienced the following with his first dose of the Pfizer vaccine. Shot was painful and in about 15 to 20 minutes later everything felt fine. But by the time he and his wife drove out of town, he started to get HOT with the sweats, terrible headache, dizziness and started to lose his vision. He pulled over to let his wife drive and by the time he got out of the car he could barely navigate to the passenger side. They turned around and headed for the hospital, 8 min away, at this time he couldn't see anything, he was nauseated but knew the hospital was pretty close. During this whole time his heart rate never raced just kept and even beat. His breathing was also just fine. By the time they got into the parking lot his vision was slowly getting better, so they sat in the parking lot for 30 minutes with the air conditioner on as high as it could go. His wife read through the side effects, he was experiencing many on the list. They left without going in. Onset of the events was reported as 12Mar2021 12:45 AM. Treatment was not given for the events. The patient recovered from the event "shot was painful" on 12Mar2021; while recovered from the rest of the events on an unspecified date in Mar2021.
Information has been received from the mother of the pt, who, subsequently, who experienced seizures and convulsions
The shot was placed too high and forward on the shoulder. Next morning, patient awoke with pain from shoulder to wrist which felt like all her "bones were breaking." Patient went to urgent care two days after vaccine, because of difficulty with such tasks as handwashing or dressing self, because of excruciating pain. Urgent care doctor confirmed vaccine injury, provided a splint for wrist, and recommended generic Voltaren gel. Splint was helpful, but gel was not tolerated by patient. Condition resolved approximately 5 days after vaccination, with no lasting effects.
4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor.  4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna.  *Migraine for 12 days, became a HA for almost a whole month.  102 FEVER lasted 7 days vomiting for 2.5 weeks  body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain  *felt like breathing bleach whole time
1/29/05, "came down sick", reports headache, sinus symptoms and was put on antibiotic to treat. 2/29/05, urinary tract infection, put of Septra. 4/05, Macrobid, states I had large swollen lymph nodes since 2/05, hardened mass ro R neck. Lab work ordered. Due to blood abnormalty, was sent to Oncologist. Abnormal monophils, neutrophils.
Father of patient was holding child who had just received an oral dose of Rotateq. The child coughed and fluid from his mouth made contact with the father's eye. Unsure if fluid was just saliva or vaccine. Eye flushed at eye wash station. Father did not have any complaints of pain or burining in the eye. Father showed copy of package insert and denies allergy to any ingredients listed. Call placed to Merck. Spoke with physician who recommended observation for now. Most likely will not contract rotavirus as it requires oral transmission and Dad has probably had the virus at some time in the past. Could have local reaction at site of splash. Needs to observe for irritation, swelling, eye pain, visual changes. If any concerning sx, needs to seek medical care. This information relayed to father. Informed that we would be doing a VAERS report. Dad verbalized understanding.
On 10/25/00, pt reports 50 cents sized red mark on arm from vaccine site with warmth to touch. Pt instructed to use ice to area and call if worsens.
Fever & aches developed around 2 pm, Lasted thru 9 pm approx. Injection site inflammed and swollen. took Ibuprophen for fever, liquids to flush system, sleep & rest.
I received the shot on 6/29/21.  Wednesday my stomach started cramping.  Thursday night my stomach started to hurt a lot more.  I had dirrhea almost constantly Friday morning 1 am - 2 pm Friday afternoon.
Two - three hours after receiving Td injection, noted muscle weakness in both arms and legs and left jaw pain (right at mandibular joint) and an increased loss of balance that have persisted for 48 + hours.  This weakness has decreased his ability to do his physical therapy exercises at the medical center by at least 50%.  No soreness at injection site noted.  Also reports large increase in number of muscle cramps in back, arms and legs.
Pt recvd 3 doses of Engerix-B  12MAR92 titer checked neg for antibodies; may be given addtl doses;
Injection site reaction. Red circular area about 3.5 inches in diameter. warm to the touch. No issues breathing.
She's experiencing chills and headache after the 2nd dose; She's experiencing chills and headache after the 2nd dose; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.   A female of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levocetirizine taking every day. On an unknown date after second dose patient experiencing chills and headache. At the time of this even outcome was unknown.   Information about lot/ batch number has been requested.
redness and itchiness at site; recommended to put ice and apply hydrocortisone cream and go to dr if worsens
Fever up and down 101.5, 102.5.; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 (Lot number: FK5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date Dec2021. The following information was reported: PYREXIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Fever up and down 101.5, 102.5."; MALAISE (non-serious) with onset 22Dec2021, outcome "unknown", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother of the patient wants to know was fever normal. She indicates she has two children, one is 8 years of age and one is 10. Received doses the same day and youngest one was fine other is not. She was asking for treatment recommendation and asks if she should/could give her something and was this normal or not. Says she was wondering if a fever was normal 2 days after the shot or not as her child has a fever. Patient had no History of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit Emergency Room or Physician Office. No Relevant Tests.
I was diagnosed with COVID-19 yesterday; I was diagnosed with COVID-19 yesterday; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot/batch number and expiration date not reported), via an unspecified route of administration on 15Mar2021 at 17:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included high blood pressure, restless leg syndrome, and allergy to Sulfa drugs. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Lisinopril and Ropinirole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was diagnosed with COVID-19 yesterday on 28Aug2021 at 06:00. Events resulted in emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 via Blood test and nasal swab both on 29Aug2021, the results were Positive for both. Therapeutic measures were taken as a result of the events included regeneron and a lot of medications. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
1st day: Chills, 2nd day: Fatigue, 3rd day: pain in pelvic region, 4th-ongoing: yeast infection in belly button
experiencing a scratchy throat; runny nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's husband stated that his wife (patient) experiencing a scratchy throat and runny nose after the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Administered Influenza vaccine on 02/27/2020 and patient had already received flu vaccine for this flu season in October 2019
Truncal rash seen in ED Rx with IV steroids in ED and 1wk po script to follow.
pounding/racing heart, profuse sweating, beats per minute are 15-20 points higher than normal and is still that way, left arm and hand is numb all the time, shortness of breath, tightness in chest, SEVERE tinnitus.  All still on-going.
Pt reporter indicated that the use of Engerix-B made employees sick, I.E., temp 103 & flu like sx;
felt that Prevnar 20 was more painful than receiving Pneumovax; This is a spontaneous report received from contactable Pharmacist from a sales representative. The reporter is the patient.  A patient of unspecified age and gender received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt that Prevnar 20 was more painful than receiving Pneumovax".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feeling dizzy; Feeling anxious; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious). At the time of the report, DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative:  Per LPN note (vaccine administrator): "Patient informed this nurse that with her first vaccine she had felt tingling sensation in her throat 15 to 20 min after her injection. This dissipated 15 min later. After Patient was given her second dose of Moderna.Instructed Patient and her husband to honk the horn if Patient had any difficulty breathing, throat or face swelling, numbness, palpations, dizziness, or other concerns. She was then sent to the 30 min observation area.Approximately 5 min after injection.Spouse alerted this nurse by honking the horn that his wife was in distress. This nurse ran over to the vehicle. Noted Patient gasping for air and slurring her speech. Called for assistance. RN and LPN assisted. Epi was administered @1040 by RN. lot #9GM744 exp date:07/21. 1054 Emergency Response Team was called 1055 vitals: 160/100, 70 pulse, 20 resp. Patient able to answer questions and appeared to no longer be in distress. 1056 police arrive. 1100 Emergency Response Team arrived and report given and Patient transported." (to ER dept) Per ER RN note: "ALLERGIES: CELEXA, NICKEL, BETA BLOCKERS/RELATED, MOXIFLOXACIN, PERCOCET ANTIDEPRESSANTS,OTHER Allergies reviewed with patient/caregiver:Yes Allergies listed in records system accurate: Yes Subjective/Chief Complaint: SOA, THROAT TIGHTNESS, DIFFICULTY SPEAKING, SLURRED SPEECH, TONGUE SWELLING, AND UNABLE TO MOVE ARMS AFTER #2 COVID VACCINE Objective: Pt was ERT at covid drive thru clinic, pt received #2 covid vaccine this morning then symptoms developed, pt was given epi pen at 1040 am, symptoms resolved pt now only feels lightheaded and fatigued."
I had my 2nd dose of the Pizer vaccine on 1/30/2021 (Saturday at 4:20pm).  The shot was given in my left arm. On 2/1/2021 Monday 10:00am) my left armpit was swollen and sore. You could visibly see the swelling. It was about the size of a lemon.  I contacted my doctor who said the reaction was normal, but I wanted to report it because it was an adverse reaction. The swelling went down but is not gone, as of today, Wednesday 2/3/2021.  I sent my doctor pictures as he is not seeing clients in person.
Patient experienced swelling and soreness.  Patient began noticing tingling as week has gone on.  Now her shoulder is numb and throbbing.
This case was reported by a pharmacist via call center representative and described the occurrence of pancreatitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the pancreatitis was unknown. It was unknown if the reporter considered the pancreatitis to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that the patient was receiving other medications and also got SHINGRIX. The pharmacist would like to know if SHINGRIX could cause pancreatitis.
Experienced a really bad allergic reaction after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination). At the time of the report, ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.