chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Situation: Patient received an additional dose of a [Pfizer] Bivalent Booster in error this morning. She had previously received a [Moderna] Bivalent Booster in October 2022. Background: Upon arrival, patient confirms with me that she is present for a Pfizer Bivalent booster. I asked the screening questions and performed a medication reconcile because she had zero history on local data tracker for any previous immunizations. Patient answers "no" to all questions on the questionnaire and I tell her that since she has no history of anaphylaxis or severe reactions to the first three doses that the 15 minute wait is optional. I administer the Pfizer Bivalent Booster. She walks out the room and I begin my documentation of her answers and vaccination when a hard stop pops up on local data tracker stating that she has completed the series. I take a look to confirm her previous vaccination history and see that she has received a Moderna Bivalent dose in October of last year. I call her back inside from the waiting area and ask her if the vaccine she had received in October of last year was a Bivalent dose and the patient confirms. I then explain to her since she has received a bivalent booster in the past that she had received today's dose in error. She states, "But that was a Moderna. Aren't I supposed to receive another Bivalent booster months later?" I explain to her that the CDC guidelines state that once you receive a bivalent booster that you have completed the series. She states that her wife was to receive another bivalent booster but I repeat that a bivalent booster will complete the vaccination series and that receiving another one will be an error. She then asks about side effects, I instruct her to keep an eye out specifically for shortness of breath and rashing and that if they are to be present to call 911 or go to urgent care.  Assessment: Upon assessment I see that she had received her three previous vaccines from local Pharmacy and the local Convention Center. The patient is fine with no allergic reactions present.  Recommendation: Lately, we have been receiving many patients who are scheduling for boosters for the same reason, believing that since months have passed since their last booster, that they are overdue for another one. They then either schedule Online or over the phone. The team grooms the schedule the day before for all patients, and we did so as well the day before this incident took place, but this patient added herself onto schedule on the day of her appointment. There should be a better system of scheduling patients to prevent error of duplicate doses. There should be a method utilized to prevent patients from booking an appointment if they have already completed the vaccination series, along the lines of a hard stop, whether they book themselves, or from medical staff or over the phone. The medical staff (myself) should and will continue screening properly, comparing CDC cards with local data tracking charting, medication reconcile as needed, and confirming that they've received the vaccinations that they have received, to prevent error.
Excruciating pain - approx 2 weeks. Weakness - ongoing. Reduced range of motion - ongoing. Chronic pain - ongoing.
This spontaneous report as received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001152, expiry date 05-JUL-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 25.1 degrees Fahrenheit for 1 hour 50 minutes cumulatively. Data logger was involved. There was previous temperature excursion which was included in cumulative total. This is one of two reports received from the same source. Additional information has been requested.
PT RECEIVED 1ST VACCINE ON 9/7/21 AND CAME IN TO GET 2ND DOSE ON 9/20/21. ACCIDENTLY GAVE 2ND DOSE NOT REALIZING ITS ONLY 11 DAYS BETWEEN DOSES
COD-changes consistent w/vax related death; Manner of death-consistent w/accident
Patient stated she began feeling tingling and itching in the arm vaccine was given. Also she noted noticeable swelling in her fingers so much her rings had to be taken off because they felt tight. She experienced all symptoms w/in 10 min of vaccine administration.
General Fatigue during the day went to sleep and had terrible shivers to violent shaking.   Fell back asleep and then awoke to being being drench.    Cotton pajamas were thoroughly wet as was bedding.   It would have taking a pint or two of water to have made this wetness.  [and no it was no urine! ;) ]  had to get new pajamas and throw a towel on the bed to have dry bedding.
This case was reported by a nurse via sales rep and described the occurrence of laceration in a adult patient who received ROTARIX (batch number A41CB558A, expiry date 5th September 2017) and (batch number A41CB573A, expiry date 17th October 2017). This case was associated with a product complaint. On an unknown date, the patient received ROTARIX. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving ROTARIX, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. The first incidence involving vial breaking when transfer adaptor attached (during preparation of vial). The other three incidences involve vials snapping' at the neck when cap is removed (during preparation of vials). It was confirmed that no product given to the patients. As per GlaxoSmithKline employee, package condition not damaged or open. It was unknown who opened the box. Medical Assistants administered product, unknown if experienced. It was unknown how stored. It was unknown if purchased directly from GlaxoSmithKline. It was unknown if carton was damaged, unknown if leakage was there in carton, unknown if glass pieces were still in vial, unknown if holes or pieces missing from vial and it was unknown if med still in vial. It was attempted to reach out to health care professional for further details. Voicemail was left with serial number. It was unknown if product was available for return, unknown if credit needed. It was unable to verify lot numbers. One of the staff members experienced the product exploding in face and got into eyes. It was unknown which of the four incidences is related to this adverse event. This case was linked to case US2017130511, reported by the same reporter.
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:
Headache, Myalgia, chills Narrative:  Employee reports feeling "sore" after receiving the second dose of the COVID-19 vaccine. Also reports chills, headache, and body aches. Reports using Tylenol for symptom relief.
fever (98-99),chills, body ache, headache, fatigue: last 24 hours. followed by coughing last 48 hours, followed by stomach ache and diarrhea: 1 hour. Feel normal after 4 days.
Here?s a list of my side effects since Saturday that I?ve experienced and some I?m still experiencing.....Sore arm, headache, bone deep muscle and joint pain, fever, nausea, vomiting , diarrhea, zero appetite, extreme fatigue, can?t get comfortable at night to sleep, can?t stay asleep, very restless, so hot I?m sweating through my clothes, so cold I?m looking for a toboggan, rash on palms of my hands that lasted about 10 hours, horrible horrible brain fog, disconnect with myself (I just feel ?off?).
Patient developed loss of vision bilaterally, described as the curtain being lowered in both eyes (amaurosis fugax).  He experienced extreme fatigue and weak, dizziness, off balance.  Felt as if his heart could not keep up with demand of walking and experienced palpitations.  The symptoms started to improve after 30minutes.  He has 2 recurrent episodes similar to this since the vaccine, over the course of 3months.  He continues to experience chest tightness on exertion and is undergoing evaluation for his heart.  Has never had known heart disease previously.  Is also experiencing tingling in upper limbs, new since vaccine without any recent history of trauma.  He feels he has more difficulty concentrating since the vaccine.
Soreness, some pain, some swelling around injection site (upper left arm); Soreness in the upper left arm
I woke up with a stye this morning/Her eyes were swollen and gooey; Her eyes were hurting; I feel uncomfortable getting the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HORDEOLUM (non-serious) with onset 12Apr2021, outcome "unknown", described as "I woke up with a stye this morning/Her eyes were swollen and gooey"; EYE PAIN (non-serious) with onset 12Apr2021, outcome "unknown", described as "Her eyes were hurting"; FEELING ABNORMAL (non-serious) with onset 12Apr2021, outcome "unknown", described as "I feel uncomfortable getting the second dose". Therapeutic measures were taken as a result of hordeolum, eye pain.  Additional information: Caller called due to take her 2nd dose tomorrow 13Apr2021 but she was uncomfortable taking the 2nd shot of the vaccine. Woke up this morning and her eyes were hurting. Her eyes were swollen and gooey and she had a stye in her eyes. She has been prescribed by her doctor an antibiotic drops for her eyes and she was told that it was an eye infection. She had this before. She wanted to know if she can wait a few more days to get her 2nd shot because she didn't want to get the covid vaccine with an eye infection. Couldn't remember when was her 1st dose. They usually go away within 4 to 5 days. Her doctor usually prescribes antibiotics and suggest putting hot compress on her eye. She feel uncomfortable getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine had expired six days prior to administration. Medical director notified, patient notified. Additional dose not recommended at this time.
Pt feels she is allergic to the shot and had all over body itching and felt as if throat swelling.  There was no swelling or redness at the injection site  she aldo had severe muscle pains.
Around 30 minutes after receiving her first COVID-19 vaccine, the patient developed chest pain and was found to have a blood pressure of 223/79, both of which lasted a few minutes and resolved.  She was brought to the ED for monitoring. Workup in the ED was negative. Patient was discharged home.
Pt recv vax on unspecified date; subsequently pt exp cellulitis at the injection site.
red rash/swelling at injection site (MMr). Resolved with antihistamines (oral).
The vaccine was given and then it was noted that the expiration date was 10/5/22- the diluent exp 3/15/25
I began having a sleep disorder where I yelled out in my sleep cuss words. I also began thrashing wildly in my sleep with arms and legs. Today, a year later I?ve found that CBD w/ THC helps limit these episodes.
Cellulitis of left arm noticeable after 48 hours. Treated with cephalexin.
2 days after the vaccine i went to the doctor, for something else, and i had significantly high blood pressure. 174/102, I have no history of high blood pressure. Doctor told me to watch my symptoms. I was not having chest pain, shortness of breath or any heart attack symptoms. Monitor it for the next 24 to 48 hours. The next day I checked my blood pressure, 185/110, At a clinic they did EKG, normal, Heart rate was fine. Rest drink water and rested. About 2 hours later they did another EKG. everything was normal, but my blood pressure was still high. I was given  Clonidine blood pressure, and it brought down my blood pressure within an hour to 2 hours. I made an appointment for the next day. My blood pressure went up again that night 170/84, and I took another Clonidine. and it came down again. The next morning , I went to my doctor , 174/106 and a real bad headache by the time I arrived at Dr. office. Doctor reported hypertension. and ordered blood work. The friday before the vaccine, I had an annual check up and I was normal,  The doctor did another EKG and it was fine. The doctor Lisinopril-hcz , diuretic , making sure she did not have a kidney infection that was causing my blood pressure to go up. Switched the meds bc my blood pressure was going to low. Feb. 8, he switched me to just lisinopril without the diuretic.
Six months to the date, 03-08-2023, after receiving the vaccine, I was feeling poorly with fever, cough, headache, myalgia. I completed a COVID-19 home test that was positive. On 03-09-2023, I had a "virtual clinic visit" with a PA from a clinic who sent in a prescription for paxlovid and sent me instructions on which medications I should stop or reduce for the 5 day treatment plus three additional days after completing the medications. By the 8th day I tested negative and was feeling well again. In my opinion, as an MD (retired), Testing positive for Covid was not related to the vaccination. It was due to exposure to the virus.
Rash (exterior and interior throat), swelling (exterior and interior throat), unable to swallow, discoloration of skin (redness) - Treatment:  Benadryl @ 09:40 AM.
Pt developed cough, chest pain, and difficulty breathing around 1/1/22. On 1/11/22 she presented to ED for treatment. She received 3 doses of Moderna COVID-19 vaccine (2/20/21, 3/20/21, & 10/20/2021). Pt tested positive for COVID 1/11/22. Uses 2L O2 at home. O2 requirement was higher throughout hospitalization.
I took the last of the 3 GARDASIL shots between Feb and March 2010. That June I noticed significant issues. My throat was swollen, I could not eat anything. Long story short, I now have Hashimoto's thyroiditis. My doctors thought it was allergies then chalked it up to plain old crazy. I am in debt because of all these medical bills of specialists telling me I am crazy, depressed, or just plain neurotic. When they finally did diagnose me, I asked them hey, could it be because of the GARDASIL shot? I never had any issues with my health other than asthma. I now have to live with the fact that my thyroid is dying. I did not think at the time, since I trusted my doctors, that it could have been from the shots or that I could have told my story and other people would have been in the same boat as me. I feel like crap every day. I took it upon myself to research this auto immune disorder online and found what I should and should not eat, and scan all these other stories just like mine.
This spontaneous report was received from a pharmacist concerning a 67 year old male patient with no pertinent medical history or concurrent conditions who on 22-JAN-2015 was vaccinated with a dose of ZOSTAVAX lot # J013133 that had expired on 17-JAN-2015. No adverse events were reported. Additional information has been requested.
Information has been received from a physician concerning his 80 year old female neighbor (not his patient) who in approximately November 2007, was vaccinated IM with a 2nd dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she developed an injection site reaction, the symptoms included low fever, local tenderness and or pain, arm weakness, swelling and redness. She told her neighbor (physician) but it was unknown if she sought medical attention. At the time of the report the patient was improving. She had received a first dose of pneumococcal 23v polysaccharide vaccine approximately one year ago. Additional information has been requested.
hard indurated knot, w/local tenderness, some swelling & redness & pain w/movement;last prev dose of vax 1989;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Pork allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with PAXLOVID from 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166921 same patient, different drug/AE;
No adverse effects reported; HCP called to report a TE with PROQUAD.  Improperly stored.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 28-AUG-2023, the patient was vaccinated with with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) (valid lot number W029555, expiration date 14-MAR-2024), administered for prophylaxis (dose number, frequency, and route of administration were not provided), after a temperature excursion (product storage error). No adverse effects reported.
Systemic: Dizziness / Lightheadness-Mild, Systemic: vasovagal rxn-Mild
vasovagal response; potential atypical reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction). At the time of the report, PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction) outcome was unknown.        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.   No relevant concomitant medications were reported.  No treatment information was provided.
Raised, blanching, red rash on arms, legs, back, no wheeze.  Benadryl 12.5mg given.
Later in the day patient stated her eyes got very watery, a lot of sneezing more than 3x in duration . other s/s stuffy nose, coughing with wheezing, slight sob included. In the evening patient stated she felt worse, woke up during the night with sob. Today Monday patient stated she feels a little better, still has stuffy nose, a little wheezing , coughing a little less.
Overwhelming nausea; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 27Feb2021 at 19:15 (at the age of 26-years old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension and generalized anxiety disorder. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 19:45, the patient experienced overwhelming nausea about 45 minutes after injection, which continued in the night and dissipated by morning and pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event overwhelming nausea which continued in the night and dissipated by morning was recovered on an unknown date in Feb2021 and the event pain at the injection site was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt. recvd. 1st dose of Hep B vax & devel diarrhea.
Suddenly, roughly 6 hours post shot, I started to feel odd and felt my body was not functioning normally.  I felt a tense squeezing feeling throughout my body and an inability to breathe deeply and calmly.  I felt panic and dread and know something was wrong.  I then, took my blood pressure and it was 200/100.  I do not have high blood pressure.  After several retakes of my blood pressure, my husband called our hospital emergency room and asked if this is something we need to immediately come in for.  They told us to contact our doctor and we did.  We called the answering service and received a call back from a triage nurse and she told us this can sometimes happen after the Covid shot.  Not to worry, unless my blood pressure doesn't come down within the next hour or if it continues to rise, I should go to the emergency room.  Luckily it came down within the next hour.  I have been extremely hesitant to get the second Covid shot, due to never ever wanting to feel the way I did that evening.  It was far worse than the Covid I had contracted in April of 2021.  I will take my chances beating Covid again, rather than feel the way I did post vaccine.