chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hib portion of pentacel was reconstituted with sterile water and administered, Dtap-IPV portion was not administered with no adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who received hib portion of diptheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dose, frequency, formulation, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information regarding the batch number for this case.  It was reported that the hib portion of pentacel was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no adverse event (single component of a two-component product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The pharmacist was enquiring if the hib portion of the vaccine would be invalid and if they would need to re-administer the whole Pentacel vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Hib portion of pentacel was reconstituted with sterile water and administered, Dtap-IPV portion was not administered with no adverse event).  At time of reporting, the outcome was Unknown for the event hib portion of pentacel was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
per MIS-C Admissin  summary: Pfizer vaccinated. 1st done 6/29/21 2nd dose 7/20/2021 per medical record. onset 8-1-2021 chest pain, subjective fever, chills and mailaise. vomiting and diarrhea. presented to ER and found hypotensive. Covid +, UA concerning for UTI. DC dx MIS-C, Hypotensive shock, Pyuria without UTI. admit 8/2-8/5.
Information has been received from a 24 year old female who was vaccinated with the first two doses of GARDASIL on unspecified dates (lot# not reported).  At the time she received the first two doses she had her menstrual cycle and after receiving it both times she had severe bleeding to the point where it soaked through everything.  The patient went to the hospital and had an internal and external ultrasound done, but the physicians could not determine why this was happening.  The patient was not admitted to the hospital.  The patient did receive the third dose of GARDASIL on an unspecified date and was fine (lot# not reported).  The patient did recover from the heavy bleeding.  Additional information has been requested.
A few months ago, I realized my penis was shrinking and had a slight upward curvature. My penis had always been perfectly straight and when erect was about 6 inches in length. Now several months have gone by and I have lost about two inches in size and have a pronounced upward curvature.  My testicles seem also to have gotten smaller and I have sensitive pain in my left one. The Pfizer vaccine has caused me to get Peyronie's Disease.
Patient fainted after receiving- afterward reported history of doing so when sees needles/ gets shots on occasion. Gave ice, had EPIPEN ready in case it was needed. She laid down, and was fine afterward.
Left arm cellulitis with onset of vesicles below injection site. C/O Lt arm pain. Bactroban oint. to apply to lesions, cefdinir 250 mg/5 ml for 10 days.
Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]; NASONEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical information: It was reported that the patient vaccinated at Health Clinic facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828044 same product/event, different patient;US-PFIZER INC-202200828046 same product/event, different patient;
Wrong vaccine.  Zostavax given instead of Varicella.  No adverse events.
Tech who administered vaccine was new and had supervisor with her. She set up the shot and then the supervisor had her move the site up my arm a few inches. The shot was incredibly painful. Far more pain than I?ve experienced from other vaccines. I was in a lot of pain afterward- couldn?t sleep without pain medication. It went away over the next couple of days. Over the course of the following week, when I lift my arm, especially if it?s left in a lifted position (like putting elbow on the back of couch) I have pain in my muscle at the injection site. It is not resolving. I?ve never experienced pain in my shoulder before injection.
On, 4/2/2021, at 6:30 pm,  I went from feeling like myself to  cold, clammy,  hot , sweaty, very nauseous and dizzy. I laid down and slept from 7:00 pm - 10pm.  Woke up for an hour then slept from  11:00 pm -10:30 am. I felt great on 4/3/2021.  On 4/4/2021, I had  a soft stool, at  9:30 am,. At 10:30, I had diarrhea with abdominal cramps that lasted  3 hours.
Received shot high upper left arm.  Began hurting in shoulder, neck, arm 2 hours later.  Worsened and I could not lift my arm without severe pain and no strength in arm.  This was 3 weeks after the shot.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered past BUD date) and product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Dec 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Dec 19, 2021, patient administered expired product (administered past BUD date). On an unknown date, patient experienced product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date). At the time of the report, administered expired product (administered past BUD date) and product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Vaccine administration error. Patient was 17 years old and was given Moderna which is approved only for >18 years old.
One week following first vaccine dose, developed joint pain in hands, wrists, elbows, knees, and ankles. Seen by PCP with no findings, seen by Rheumatologist with no findings. X-rays performed-normal. Bloodwork normal other than elevated autoimmune markers which is roasted to Hashimoto?s Thyroiditis. Join pain has Been continuous and remains as it was when it developed. No prior joint issues noted.
VARIVAX booster given 9/14/12. Pt. diagnosed with shingles 10/26/12.
Patient said she had immediate pain once injection was given. She noticed it was given too low, in the subcutaneous tissue, not in the deltoid. The pain was severe immediately after the injection. The injection site and tissue on lower upper arm towards elbow is red, inflamed, painful and hot-to-touch. This occurred gradually over the last 30 hours post-injection. She denied any reaction after first 2 doses other than sore muscle.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Following the first injection, the patient developed pain, swelling and redness. She was not hospitalized and has recovered fine. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number unknown). On an unspecified date, one day after the GARDASIL was administered, the patient developed pain, swelling and redness. The patient was not hospitalized and has recovered fine. Additional information is not expected.
Friday afternoon, 4/12/19, face became itchy and developed hives, took BENADRYL, came to pediatrician. Left earlobe also red, itchy. Took BENADRYL again Friday night. Symptoms resolved. Took ZYRTEC Saturday, symptoms did not return.
COVID+ 11/8/2022 - Vaccination status J&J x1 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Physician at Discharge: DO   Admission Date: 11/8/2022   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 11/09/2022 Unknown ? Acute hypoxic respriatory failure due to COVID-19   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: AKI (acute kidney injury)  [N17.9] Supratherapeutic INR [R79.1] Hematoma of rectus sheath, initial encounter [S30.1XXA] COVID [U07.1] COVID-19 [U07.1] Respiratory arrest [R09.2]   HOSPITAL COURSE: Patient is a 69 y.o. male with a past medical history of metastatic prostate cancer, hypertension, hyperlipidemia, GERD, rheumatoid arthritis who presents today with symptoms of severe abdominal pain, cough and shortness of breath.  Patient states that he has been congested for approximately the last month with his significant other testing positive for COVID-19 1 week ago. He has continued coughing with sudden development of abdominal pain from coughing so much.   Upon arrival to facilitY, imaging was performed showing large right rectus sheath hematoma without evidence of active bleeding.  Patient does take Coumadin at home and was noted to be supratherapeutic on coagulation studies.  Patient was also found to be COVID-19 positive with no evidence of pneumonia on chest x-ray.  Patient did receive 1 dose of vitamin K in the emergency department for supratherapeutic INR of 8. Patient was initially admitted today oncology service for further treatment. While on the floor he had significant desaturation and ultimately a code blue is called. He receives one round of compressions and epinephrine and ROSC is achieved. He is intubated and requires multiple pressors for circulatory support.    Upon admission to the ICU the patient has a central and arterial line placed. He is found to have a 3g Hbg drop and has increasing pressor requirements. During his stay in the ICU he eventually required CRRT for worsening kidney function. He required 4 pressors and stress dose steroids with poor prognosis.  On 11/11/2022, resident team called significant other and 1st degree sister to discuss ongoing need for dialysis and raising pressor requirements despite adequate volume resuscitation.  Both of them agreed in his current state he would not want repeat resuscitation with chest compressions and code status was changed to do not resuscitate.  Around 8:00 p.m. on the same day, patient's pressor requirements increasing and lactate continues to up trend. Patient's significant other as well as only first degree sister were contacted regarding worsening clinical status. Both expressed that patient would have not wanted to pursue aggressive medical care in this clinical sitting as things don't seem to be improving. Goals of cares were discussed and both parties expressed their wishes totransition to comfort care.  At around 3:15 a.m., resident team called to bedside to pronounce patient death.  Patient was seen and examined, time of death was 3:25 a.m. on 11/12/2022.
Myalgia, Fever, Injection Site Soreness day 1-2, Fever, Body Aches, Fatigue day 3-5 Narrative:  Other Relevant History:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JAN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 31-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Woke up screaming in pain, I thought she had a fever but didn't have a chance to take her temperature. She went unresposive within 4 or 5 mins of waking. Eyes stuck in downward gaze and she stiffened and turned blue around lips. I called 911 immediately and she was rushed to the hospital via ambulance to a nearby city. She was having a seizure and unresponsive to pain and everything and it lasted a little over an hour until 2 differrent seizure medications were administered at the hospital.
My arm has a welt where I got the shot, and it is also red wnd itchy.
Flu symptoms. Headache, nausea, fever, chills, aches. Treated as if it were the actual flu (liquids and Tylenol).
This is a spontaneous report from a contactable medical office staff member reporting on behalf of a Physician communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on 12May2016. The patient medical history included that her brother had been exposed to meningitis in the past. Concomitant medications were not reported. The patient previously received MENACTRA when she was 13 or 14 years old. In May2016 (within 12 hours of receiving the vaccine), the patient experienced pain in her leg, spine and neck, chills, fever, lethargic, it was as if she could not even walk on her own. The patient underwent lab tests and procedures on 13May2016 which included temperature 99 degrees Fahrenheit, blood pressure normal and a Negative Rapid Strep Test. The outcome of the events was unknown. Follow-up (27Sep2016): Follow-up attempts are completed. No further information is expected.
Patient received Novavax as 2nd booster due to inability to receive mRNA COVID-19 vaccine due to prior allergic reaction
Had rash on arms, chest, and abdomen and persisted x few months after d/c. Possible relation to vaccine.
31 year old M received first dose of Pfizer vaccine to left deltoid at 1622. About 5 minutes later after sitting down in a chair for observation pt c/o dizziness, pt stated he "started to loose sense of hearing and sight, and started to loose consciousness" but did NOT have syncopal episode. Pt also c/o "weird sensation in chest" but when inquired about chest statement pt denied CP, any radiating pain, pt denied like an elephant was sitting on his chest. Pt did state "weird sensation in chest" could of been related to anxiety but was not too sure. Upon nurse assessment pt had pallor look skin, very noticeable on the lips. Pt was immediately brought ice water, vital signs (VS) taken, fan was applied towards patient, ice pack applied on back of patient's neck, legs were propped up on a second chair for venous return. VS taken at 1628 were as followed 141/120. SpO2 100 RA, HR 61, VS at 1635 95/35 (61), SpO2 100% RA, HR 65.   Pt stated he did not have a good source of nutrition/meal the day of the vaccine. He reported he are two hours prior to the vaccine and he stated he only ate "a smallpiece of bread, hard candy, pumpkin butter, and cereal for breakfast". Pt educated and adviced on importance of having a nutritious meal on the day of the vaccine.   Pt was taken down to nurse treatment room via wheelchair and report was given to charge RN in nurse treatment room. Pt reported symptoms were improving and he felt better as well. Pt's skin color and lip color was improving and pallor was resolved.
Staff had his 1st vaccine yesterday 01/14/2021.  Around 10 pm last night started having symptoms; bodyache, hot and cold.  Staff had positive Covid test on 12/07/2020.
overall itching of the skin, internal like going to get hives, but NO rash or hives. No try skin, as already treated by both general physician and demitologist with various locations, creams and steroids. Very difficult to wear clothing and sleep at night. Sometimes hands get red and  feel like on fire. No  break out at injection site.
Menstrual cycles every other week; This is a spontaneous report from a contactable nurse, the patient.   A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 15:00 (at the age of 50-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 07:00, since the vaccination, the patient started having menstrual cycles every other week which lasted for 5-6 days. However, prior to the vaccination the patient had a regular cycle of every 28 days. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event menstrual cycles every other week was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 12/10/2022, I was finishing up my day at work when I began to feel lightheaded. I went home and took a nap. When I woke up, I was experiencing flu like symptoms. I had fever, diarrhea, stomachache. I was treating with over-the-counter medication. After a few days, when the fever did not go away, I went to the medical center where they diagnosed me with pneumonia. They prescribed, antibiotics, guaifenesin, benzonatate. After around five days, I felt fine and am still doing well.
administered daptacel instead of adacel with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2023SA264528(CLUSTER).  This case involves a 12 years old female patient who was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine (Polio Vaccine); varicella zoster vaccine (Varicella Vaccine) and hepatitis B vaccine (HEP B VAX) for Prophylactic vaccination (immunization).  On 24-Aug-2023, the patient received a dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot C5969AD expiry date:17-Feb-2024 via intramuscular route in the left arm for immunization instead of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection with no reported adverse event (wrong product administered) on the same day following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered daptacel instead of adacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Began w/ sore throat - tickle - then tight. Kept coughing. Used own albuterol inhaler.
fever; lingering cold symptoms; cold/flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) reported for herself.  A 39-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK9231, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 07Jan2021 at 10:45 am (age at vaccination was 39 years) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included high cholesterol and pre-diabetic. The patient had known allergies to pcn and sulfa drugs. Concomitant medication patient received within 2 weeks of vaccination included ibuprofen, atorvastatin and vitamins nos (DAILY MULTIVITAMIN). On an unknown date, the patient experienced fever, cold/flu like symptoms for 4 days, lingering cold symptoms for over a week. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.