chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 13:15 as dose number unknown, single (Lot number: ENG200), in left arm and on 24Mar2021 at 13:15 as dose number unknown, single (Lot number: ENG204) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "DCIS Breast Cancer Diagnosis", start date: 2015 (unspecified if ongoing), notes: DCIS Breast Cancer Diagnosis in 2015; "Asthma" (unspecified if ongoing), notes: recovered and diagnosis on Asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Mar2022, outcome "not recovered" and all described as "I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening; (08May2022) Negative, notes: I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days; (09May2022) Negative, notes: I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days; (15May2022) Positive, notes: I began having symptoms again on 14May and 15May22. I tested positive again on 15May. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: If vaccine received- Yes; other medication in 2 weeks- unknown. Adverse event: I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening. I started taking Paxlovid on the afternoon of 5May22 and took it as instructed for 5 days. I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days. I began having symptoms again on 14May and 15May22. I tested positive again on 15May. Known allergies- No
About 1pm I got really tire and sleepy. About 6pm I started getting small headache. Not serious. But at 1 am in the morning of May 5th I started having stomache pain cramping. Alos cols childs ,that lasted for 4 hrs. Unable to sleep. Finally after 4 hrs the chills subsided. I was able to sleep a couple hours. BY 10 am on May 5th I was able to get up and eat some breakfast. Also had swelling of shot location like a hard knot. Still there as of 11:30am.  Had some loose stool and pains in stomach. I        talked to many people who had the Maderma and no one had any of these systems. This means I will really be sick for the second shot.
10-21-09-4:00 AM awoke with welts on inside of both forearms-subsided throughout the day. 10-22-09 4:00 AM awoke with welts on outside of both forearms, itchy, swollen lower lip-subsided throughout the day.
This is a spontaneous report from a contactable pharmacist. This contactable Pharmacist reported for a male patient. A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 10Aug2021 the patient experienced he developed bumps yesterday. Reporter stated a patient had a reaction to the Pfizer COVID vaccine after receiving the vaccine on Monday, 09Aug2021. Reporter stated he developed bumps yesterday, 10Aug2021 on his injection arm from the elbow to his wrist, but not at the injection site. The red bumps are not itchy nor hurting, but it's just there. Reporter is wondering if this has ever been reported. Escalated as reporter wants to know if there have been specifically any reports of bumps that is not at the injection site but in the injection arm from the elbow to the wrist. Sent reports of allergic reactions and anaphylaxis SRD. Outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.
General malaise day after administration, persisting 1 week.  No injection site swelling or soreness.  Cognitive changes and "blurry vision" noticed 2.5 days post vaccination.  Cognitive deficits involve short term memory which is impaired enough to be noticeable not only to patient, but elicits unprompted comments from friends and family.   Vision is has improved to nearly pre-vaccination quality, but short term memory deficits remain and seem to be somewhat stable at 5 weeks post-vaccination.   Development of neurological symptoms associated with administration of vaccine.
Approximately 3  minutes after injection body felt numb, did not  and after an additional 5-10 patient began to experience throat tightness. Benadryl  25mg IM administered.
Tested positive for COVID 19 after receiving both doses; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses) in an 89-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.; Sender's Comments: This report concerns a 89 year old female patient with no relevant medical history who tested positive for COVID-19 (non-serious and unexpected). The event occurred after an unknown duration following vaccination with second dose of mRNA-1273. The report states that the patient tested positive for COVID-19 after receiving two doses of mRNA-1273. Re-challenge was not applicable as the event happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273  is not affected by this report.
Patient recieved the spikevax Moderna vaccine after the use-by-date. Patient was informed and will come get a new vaccine in the next day or 2. No adverse effects were reported.
Expired Bexsero administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number 59m3m, expiry date 28-FEB-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-APR-2023  The pharmacist reported a patient received an expired dose of Bexsero on the day of reporting.  The pharmacist did not had patient details.  The reporter consented to follow up via email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
This spontaneous report as received from a nurse refers to a 6 months 15 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
The first day, I had fatigue (tiredness) and  little bit of soreness in the arm of the injection. It was later on that night that I had to use my other arm to get my arm up to a cabinet to reach something. I went to bed early. The next day, still very fatigued, I still had the soreness in the muscle in the injection site arm. 10:30 am at work - it hit me almost like a flu - really quick that I started to feel very bad. Headache - light a migraine - it encompassed my whole head and started having low grade fever and severe nausea and abdominal pain and chills and severe body aches and bone achiness. Extreme fatigue. Side that I got the vaccine in, the glands in my neck and under my arm were swollen.  My fever was never only 100 - but 99.6 is where it usually ran and that was unusual for me to have a fever that high. I had had shingles about two years ago that affected my left side. I started to feel like my shingles was coming back. This felt like it was going to go from trunk all the way up to my neck (the shingles) - it didn't. I did have a few areas on my trunk area on that left side that did start - like a burning pain - no itchiness but they did go away. I had  flushing feeling - it was worse than a hot flash and different - it was like my body was extremely hot. My coworkers told me that I looked red as a bright red apple - and I wear makeup and had a face mask on. That continued for about 5 days - face, cheeks, especially below my chin, neck and my trunk - just really red. I have a photo of it. There was no pain to it - just hot flushing feeling. That was different from the shingles. The headache never went away - seven days - had trouble sleeping it was painful. It was almost like I had  flu. I had also increased aura migraines - this aura was squiggly lines instead of usual round. I felt like my chest was tight over the weekend. Like it might be going to my chest - Pulsometer - I check my pulse and my blood oxygen level - it went down to about 92 or 94% and I felt  a little short of breath and that lasted about two days.  I did not check my blood pressure.  The only other thing, like if you have the flu for ten days etc which is what my symptoms lasted- but the fatigue lasted another week past these severe intense reactions.
dizziness,hoarseness,redness a 12:00pm. No n,v,d. Report to medical at 1:00pm. Rest w/benodryl 50mg. Improvement at 14:20. Stable vital signs. Release at 14:30.
Pt screamed and grabbed her chest.  Vitals taken w/ 178 other vitals WNL.  Pt reported chest pain and pain in the back of her head.  Pt rated 10/10.  Pt also reported feeling heavy and dizziness.  911 called immediately.  Pt placed in wheelchari and assessed by RN.  Pt transported to ED. IN ED: 46-year-old presenting for palpitations status post COVID vaccine, no evidence of anaphylaxis, complains of substernal chest pressure as well no history of ACS or recent ACS workup -history is not consistent with ACS however patient reports substernal chest pain at this time.  Started 20 minutes prior to presentation discussed risk benefits of further work-up, patient preferred to have ACS work-up here in the emergency department. Differential diagnosis includes ACS, pulmonary embolism, pneumothorax, pneumonia, cardiac tamponade, esophageal rupture, pericarditis, myocarditis. 1107 My interpretation of the EKG is sinus rhythm, rate of 62, short PR interval 105, no delta wave, normal axis, no ST elevations meeting STEMI criteria.  1300 Troponin T high sensitivity: <6 Pending delta Trope.  1355 Pt will be Be signed out to oncoming ED attending Dr. pending delta Trope.  Patient is a low risk chest pain if COVID-negative patient okay for discharge.  Doubt ACS.  Patient is now chest pain-free on my reevaluation.  1403 SIGNOUT: pending hstrop3 for DC  1403 S/o: 46F low risk chest pain, pending 2nd trop, if neg can go home  1510 Troponin T high sensitivity: <6 After re-evaluation, patient was clinically improved. Pertinent diagnostic results discussed with the patient. All questions were answered. Return precautions discussed as well as pertinent wound/injury care instructions. Utilizing shared decision making, patient will be discharged home. Patient agrees to close follow up with their primary care physician and appropriate outpatient specialist.   1510 Doubt ACS.  Low risk for major adverse cardiac event, less than 1.7%.  Heart score of 1.  Patient informed of results and agreeable.  Pt discharged home with return precautions.
injection site where it's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site where it's sore) 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) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site where it's sore). At the time of the report, VACCINATION SITE PAIN (injection site where it's sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication was not provided.   Treatment information was not provided.
never got second dose; Excessive perspiration; Horrible Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never got second dose), HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never got second dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (never got second dose), HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021 contains significant information. Patient contact details and event details has been updated.
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and in 2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Information was received on 17-JAN-2017 from a physician who was reporting on a six month infant (no age or gender reported). On 16-JAN-2017, the patient inadvertently received a dose of  RECOMBIVAX HB (no lot or injection site reported)"2.5/0.5 ml" (pediatric dose 5 mcg/0.5ml)  instead of  ACTHIB (Sanofi Pasteur)(lot, dose and injection site not reported) that was given concomitantly with a dose of PEDIARIX) (GLAXOSMITHKLEIN)(lot, dose and injection site not reported). The physician reported that the error occurred because she inadvertently verbally ordered "PEDIARIX and hepatitis B vaccine" when she had intended to say "PEDIARIX and Hib vaccine". No adverse effect reported. No additional information was provided. Additional information has been requested.
Grand mal seizure at home, another in ER an hour later. No previous history. Eyes rolled back, tonic contractions, foaming at mouth. No incontinence.
Severe flare of leukocytoclastic vasculitis, exacerbation of underlying condition previously well controlled
rash onset 7OCT97;freckled on face, more solid on trunk;rash flat, not raised, non in warm areas (egg axilla);fever onset late 7OCT97 or early 8OCT97 T100 upon awakening on 8OCT97;fever & rash gone by 9OCT97;
Before the vaccine, I had a very predictable cycle.  Because of the tracking app on my phone, I can see that since July 2016, my cycles last 28 days on average and I menstruate for 8 of those days.  My cycle after the first vaccine was heavier and longer.  My cycle after the second vaccine had to be stopped with medication.  By the time I got a medical professional to believe my claim that my cycle was out of control, I was on Day 8 of my cycle, hemorrhaging, and almost needing a blood transfusion.  On Day 4 of this cycle, the bleeding increased.  By Day 6, I had large amounts of clots.  By Day 8, I soaked through an ultra-tampon and an overnight pad on the thirty minute drive to the medical professional?s office.  I was also feeling weak and dizzy. Lysteda stopped my cycle on Day 12.  Sixteen days later my cycle started again.  It came on heavier than my pre-vaccine cycles and I had to take Lysteda to stop it again.  Most recently, I menstruated for 10 days, had 9 days of no bleeding, and then menstruated for another 10 days. A recent ultrasound has shown that I have fibroids.  That wasn?t a surprise because I had already been told that I had fibroids. Also, I am 52. So, most of the medical community wants to tell me that it is my age and my fibroids causing the problem. The ob/gyn I have seen is insisting that the literature indicates that only the first cycle after following the vaccine is affected. My point is that before receiving the vaccine I was 52, with fibroids, and a very predictable cycle.  I just want my voice to be heard and have the medical community acknowledge the fact that the vaccine has caused some sort of change with my cycle.
Information has been received from a medical assistant concerning a 46 month old male with no medical history and no allergies who on 05/25/2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 638568/1888K).  Concomitant vaccination the same day included a first dose of measles-mumps-rubella vaccine (MSD) (lot3 636776/0021L) given subcutaneously, a third dose of HIB conj-hepatitis B vaccine (MSD) (lot#638841/1762K) given intramuscular, a second dose of pneumococcal 4 6b 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot # 479-240) given intramuscularly and a third dose of diphtheria toxoid pertussis acellular 3-component vaccine, tetanus toxoid (Infanrix) (lot# DTPa982A2) given intramuscularly.  The mother of the patient reported that on 04/05/2004 the patient developed lesions all over his body and had a fever for the last 2 days.  The medical assistant reported the AE as chickenpox breakthrough.  Unspecified medical attention was sought and the patient was prescribed cetirizine hydrochloride (Zyrtec) and pimecrolimus (Elidel) but the mother never filled the pimecrolimus (elidel).  No product quality complaint was involved.  Follow up information from the licensed practical nurse indicated that the patient was seen on 04/05/2004 with a raised rash that progressed in the next 24 hours into a widespread varicella rash.  It was noted that the rash started on 04/04/2004.  Subsequently the patient recovered.  It was also reported that the patient's brother had a similar experience following exposure to varicella virus vaccine live (Oka/Merck).  No further information is expected.
Her arm still hurts/she can't sleep on that arm; Hurts when she takes a group picture because she can't lift her arm like that; She is swollen under the armpit area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area). At the time of the report, PAIN IN EXTREMITY (Her arm still hurts/she can't sleep on that arm), MOBILITY DECREASED (Hurts when she takes a group picture because she can't lift her arm like that) and LYMPHADENOPATHY (She is swollen under the armpit area) had not resolved.            No relevant concomitant medications were reported.  Patient has seen her gynecologist and primary care doctor and was told to wait 6 months to see how she feels and the 6 months has come and gone. Treatment includes application of heat to the area but patient is still experiencing these events.
pt recv vax 23SEP97 & 1 or 2 days p/vax pt exp myalgia, flu-like sx, nausea & h/a;from f/u 20OCT97 it was reported, prescribed valtrex 500mg tid;pred x 2 days;
Mom stated her child was driving home from health dept when child started complaining of a rash on face that was itchy around 3:45-4pm. Mom and child came back to health dept at 4pm. Nurse saw pt  came to reception window and noted chil had hives and immediately took child to see nurse practitioner. Epinephrine and Benadryl was given.